| 1. |
- Dahm-Kähler, Pernilla, 1964, et al.
(author)
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Population-based study of survival for women with serous cancer of the ovary, fallopian tube, peritoneum or undesignated origin - on behalf of the Swedish gynecological cancer group (SweGCG)
- 2017
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In: Gynecologic Oncology. - : Elsevier BV. - 0090-8258 .- 1095-6859. ; 144:1, s. 167-173
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Journal article (peer-reviewed)abstract
- Objective. The aim of the study was to determine survival outcome in patients with serous cancer in the ovary, fallopian tube, peritoneum and of undesignated origin. Methods. Nation-wide population-based study of women 18 years with histologically verified non-uterine serous cancer, included in the Swedish Quality Registry for primary cancer of the ovary, fallopian tube and peritoneum diagnosed 2009-2013. Relative survival (RS) was estimated using the Ederer II method. Simple and multivariable analyses were estimated by Poisson regression models. Results. Of 5627 women identified, 1246 (22%) had borderline tumors and 4381 had malignant tumors. In total, 2359 women had serous cancer; 71% originated in the ovary (OC), 9% in the fallopian tube (FTC), 9% in the peritoneum (PPC) and 11% at an undesignated primary site (UPS). Estimated RS at 5-years was 37%; for FTC 54%, 40% for OC, 34% for PPC and 13% for UPS. In multivariable regression analyses restricted to women who had undergone primary or interval debulldng surgery for OC, FTC and PPC, site of origin was not independently associated with survival. Significant associations with worse survival were found for advanced stages (RR 2.63, P<0.001), moderate (RR 1.90, P<0.047) and poor differentiation (RR 2.20, P<0.009), neoadjuvant chemotherapy (RR1.33, P<0.022), residual tumor (RR 2.65, P<0.001) and platinum single (2.34, P<0.001) compared to platinum combination chemotherapy. Conclusion. Survival was poorer for serous cancer at UPS than for ovarian, fallopian tube and peritoneal cancer. Serous cancer at UPS needs to be addressed when reporting and comparing survival rates of ovarian cancer. (C) 2016 Elsevier Inc. All rights reserved.
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| 2. |
- Grundström, Hanna, 1982-, et al.
(author)
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Incidence of self-reported pelvic pain and risk factors for pain 1 year after benign hysterectomy : A register study from the Swedish National Quality Registry for Gynecological Surgery
- 2023
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In: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 102:10, s. 1359-1370
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Journal article (peer-reviewed)abstract
- Introduction The primary aim of this study was to determine the incidence of patient-reported pain 1 year after hysterectomy for benign gynecological conditions in relation to occurrence of preoperative pain. The secondary aim was to analyze clinical risk factors for pain 1 year after the hysterectomy in women with and without preoperatively reported pelvic/lower abdominal pain. Material and methods This was a historical cohort study using data from the Swedish National Quality Registry for Gynecological Surgery on 16 694 benign hysterectomies. Data were analyzed using multivariable logistic regression models. Results One year after surgery, 22.4% of women with preoperative pain reported pelvic pain and 7.8% reported de novo pelvic pain. For those with preoperative pain younger age (adjusted odds ratio [aOR] 1.75, 95% confidence interval [CI] 1.38-2.23 and aOR 1.21, 95% CI 1.10-1.34 for women aged <35 and 35-44 years, respectively), not being gainfully employed (aOR 1.43, 95% CI 1.26-1.63), pelvic pain as the main symptom leading to hysterectomy (aOR 1.51, 95% CI 1.19-1.90), endometriosis (aOR 1.18, 95% CI 1.06-1.31), and laparoscopic hysterectomy (aOR 1.30, 95% CI 1.07-1.58), were clinically relevant independent risk factors for pelvic/lower abdominal pain 1 year after surgery, as were postoperative complications within 8 weeks after discharge. Meanwhile, clinically relevant independent risk factors for reporting de novo pain 1 year after surgery were younger age (aOR 2.05, 95% CI 1.08-3.86 and aOR 1.29, 95% CI 1.04-1.60 for women aged <35 and 35-44 years, respectively), and postoperative complications within 8 weeks after discharge. Conclusions The incidence of pelvic pain and de novo pain 1 year after hysterectomy was relatively high. Women with and without reported preoperative pelvic/lower abdominal pain represented clinically different populations. The risk factors for pelvic pain seemed to differ in these two populations. The differences in risk factors could be taken into consideration in the preoperative counseling and in the decision-making concerning method of hysterectomy, provided that large well-designed studies confirm these risk factors.
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| 3. |
- Olsson, Cecilia, 1971-, et al.
(author)
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Adaption of the Quality From the Patient’s Perspective Instrument for Use in Assessing Gynecological Cancer Care and Patients’ Perceptions of Quality Care Received
- 2022
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In: Cancer Care Research Online. - : Wolters Kluwer. - 2691-3623. ; 2:1
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Journal article (peer-reviewed)abstract
- Background: Research focusing on patients’ perceptions of the quality of gynecological cancer care is needed.Objective: To adapt the Quality from the Patient’s Perspective instrument for use in gynecological cancer care (QPP-GynCa) and describe patients’ perceptions of their quality of care in terms of the care received and the subjective importance of the aspects of care.Methods: A cross-sectional study 6–8 months after diagnosis was conducted, involving 1511 patients (response rate of 50.4%) included in the Swedish quality registry for gynecologic cancer.Results: The exploratory factor analysis (n = 1431) resulted in the QPP-GynCa with a 5-factor structure and an eigenvalue of ≥1, explaining 73.1% of the total scale variance. The final 27-item version of the QPP-GynCa consisted of 18 items with 8 additional single items and 1 global single item. The Cronbach’s alpha was acceptable for most factors (>.80). Subjective importance scores were higher than corresponding quality of care scores for care received (P ≤ .01)in all dimensions, factors, and items.Conclusions: The QPP-GynCa instrument reflects all 4 dimensions of the theoretical model of quality of care and achieved good validity as a reliable instrument in assessing the quality of gynecological cancer care.Implication for Practice: Information related to self-care, aspects of sexuality, and reducing patient waiting times need improvement.What Is Foundational: This study contributes to a better understanding of quality of gynecological cancer treatment and care. The validated QPP-GynCa instrument will be a platform for more research on how this group of patients experience their received care, as well as importance of each aspect of care.
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| 4. |
- Radestad, A. F., et al.
(author)
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Long-term incidence of endometrial cancer after endometrial resection and ablation: A population based Swedish gynecologic cancer group (SweGCG) study
- 2022
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In: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 101:8, s. 923-930
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Journal article (peer-reviewed)abstract
- Introduction Minimally invasive methods to reduce menorrhagia were introduced in the 1980s and 1990s. Transcervical endometrial resection (TCRE) and endometrial ablation (EA) are two of the most frequently used methods. As none of them can guarantee a complete removal of the endometrium, there are concerns that the remaining endometrium may develop to endometrial cancer (EC) later in life. The primary aim was to analyze the long-term incidence of EC after TCRE and EA in a nationwide population. The secondary aim was to assess the two treatment modalities separately. Material and Methods The Swedish National Patient Registry and National Quality Registry for Gynecological Surgery were used for identification of women who had TCRE or EA performed between 1997-2017. The cohort was followed from the first TCRE or EA until hysterectomy, diagnosis of EC, or death. Follow-up data were retrieved from the National Cancer Registry and the National Death Registry. Expected incidence for EC in Swedish women was calculated using Swedish data retrieved from the NORDCAN project after having taken into account differences of age and follow-up time. Cumulative incidence of EC after TCRE and EA, was calculated. A standardized incidence ratio was calculated based on the expected and observed incidence, stratified by age and year of diagnosis. Results In total, 17 296 women (mean age 45.1 years) underwent TCRE (n = 8626) or EA (n = 8670). Excluded were 3121 who had a hysterectomy for benign causes during follow up. During a median follow-up time of 7.1 years (interquartile range 3.1-13.3 years) the numbers of EC were 25 (0.3%) after TCRE and 2 (0.02%) after EA, respectively. The observed incidence was significantly lower than expected (population-based estimate) after EA but not after TCRE, giving a standardized incidence ratio of 0.13 (95% confidence interval [CI] 0.03-0.53) after EA and 1.27 (95% CI 0.86-1.88) after TCRE. Median times to EC were 3.0 and 8.3 years after TCRE and EA, respectively. Conclusions There was a significant reduction of EC after EA, suggesting a protective effect, whereas endometrial resection showed an incidence within the expected rate.
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| 5. |
- Wedin, Madelene, et al.
(author)
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Validation of the Lymphoedema Quality of Life Questionnaire (LYMQOL) in Swedish cancer patients
- 2020
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In: Acta Oncologica. - : Taylor & Francis. - 0284-186X .- 1651-226X. ; 59:3, s. 365-371
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Journal article (peer-reviewed)abstract
- Background: The aim of this study was to validate a translated Swedish version of the lymphoedema-specific quality of life questionnaire (LYMQOL) in a cohort of Swedish cancer patients with secondary lymphoedema of the limbs after cancer treatment.Material and methods: We recruited 102 patients with lymphoedema of the arms or legs after cancer treatment who were visiting lymphoedema therapists at the departments of oncology at the university hospitals in Linköping and Umeå. The LYMQOL questionnaires were translated forward and backward from English to Swedish. Content and face validity were evaluated. The construct validity was assessed by comparing the LYMQOL with the Short Form Health Survey (SF-36) and the perceived degree of lymphoedema of the limbs, respectively. Reliability was determined through test-retest. The internal consistency was assessed by determining Cronbach’s alpha and by factor analysis.Results: The content and face validity assessments showed that LYMQOL was an easy, clear and not too long questionnaire to use for patients with lymphoedema. Construct validity was high in both versions when compared with the SF-36. The association between the degrees of perceived lymphoedema and the LYMQOL was only significant in the domains Function and Body Image in the arm version, whereas all domains in the leg version were significant. The reliability was good for the arm version (intra-class-correlation coefficients 0.53–0.87) and very good for the leg version (intra-class-correlation coefficients 0.78–0.90). The internal consistency was acceptable to excellent, with Cronbach’s alpha values between 0.79–0.93 (arm-version) and 0.87–0.94 (leg-version). The factor analysis confirmed the usefulness of the four domains in the LYMQOL versions.Conclusions: This study confirmed the validity of the Swedish version of LYMQOL and demonstrated that LYMQOL may be a simple and useful tool for use in clinical practice and scientific contexts for evaluating QoL in patients with lymphoedema of the limbs.
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| 6. |
- Borendal Wodlin, Ninnie, 1962-, et al.
(author)
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Influence of Regional Analgesia on Self-Reported Quality of Sleep After Gynecological Abdominal Surgery : A Secondary Analysis of a Randomized Trial
- 2024
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In: Journal of Obstetrics and Gynaecology Canada. - : Elsevier Inc.. - 1701-2163. ; 46:1
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Journal article (peer-reviewed)abstract
- Objectives: To determine whether intrathecal morphine (ITM) analgesia in abdominal surgery for presumed gynecological malignancy was associated with better self-reported sleep quality postoperatively compared with epidural analgesia (EDA), and to evaluate risk factors for bad sleep quality. Methods: A secondary analysis of a randomized open controlled trial, comparing ITM and EDA as postoperative analgesia in 80 women undergoing laparotomy under general anaesthesia in an enhanced recovery after surgery framework. A total of 38 women allocated to ITM and 39 to EDA completed the study. The Swedish Postoperative Symptoms Questionnaire assessed symptoms and sleep quality during the first postoperative week. Multiple logistic regression models evaluated risk factors. The results are presented as adjusted odds ratios with 95% CIs. Results: The sleep quality night-by-night did not differ significantly between the women who had ITM or EDA. Risk factors for bad sleep quality for night 1 were age (0.91; 0.84–0.99), operation time (1.02; 1.00–1.03), and opioid consumption (0.96; 0.91–0.99). For night 2, regular use of hypnotics preoperatively (15.81; 1.52–164.27) and opioid consumption (1.07; 1.00–1.14) were independent risk factors for bad sleep. After the second night, no risk factors were disclosed. Conclusions: ITM and EDA did not appear to affect the sleep quality postoperatively differently in women undergoing laparotomy for presumed gynecological malignancy. Risk factors for self-reported bad sleep quality varied during the first 3 days after surgery. Younger age, longer operation time, and preoperative use of hypnotics were associated with bad sleep quality, whereas the effect of opioid consumption on sleep quality varied depending on the time since surgery. These findings merit further studies. © 2023 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada
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| 7. |
- Dahl, Christian, et al.
(author)
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Obstetric anal sphincter rupture in older primiparous women : A case-control study
- 2006
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In: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 85:10, s. 1252-1258
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Journal article (peer-reviewed)abstract
- Objective. To determine if maternal age (35 years of age or older) in primiparous women is a risk factor for the development of obstetric anal sphincter rupture (OASR) and to identify obstetric factors associated with it. Material and methods. This is a retrospective case-control study. The study population was made up of the 5,345 primiparous women aged 24-45 years who delivered vaginally with singleton live-born neonates during 1990-99 at the Department of Obstetrics and Gynecology, Linköping University Hospital, Sweden. As cases the 327 primiparous women aged 35-45 years at delivery were selected. For each case two primiparous controls ten years younger were selected, matched for gestational age and year of delivery, in all 654 controls. Maternal, obstetrical, and neonatal data were obtained from the delivery records. Obstetric factors for the development of OASR were assessed with multivariate logistic regression analysis. Results. No significant association was found between the primiparous age category and OASR. Vacuum extraction, forceps delivery, and the head circumference of the neonate were found to be independent risk factors for OASR, while the use of mediolateral episiotomy or epidural analgesia were independent protective factors for developing OASR. Conclusions. Primiparous women, 35 years of age or older, do not seem to have a greater risk of OASR than younger primiparous women. Risk factors for OASR are instrumental vaginal delivery and the size of the neonate. Mediolateral episiotomy and epidural analgesia seem to reduce the risk for OASR. © 2006 Taylor & Francis.
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| 8. |
- Grundström, Hanna, 1982-
(author)
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Disclosing the invisible : experiences, outcomes and quality of endometriosis healthcare
- 2018
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Doctoral thesis (other academic/artistic)abstract
- Introduction: Many women with endometriosis report that their symptoms are normalized and trivialized when they seek medical care and they often experience diagnostic delays, ineffective treatments and physiological, psychological and social consequences. However, there is a knowledge gap when it comes to women’s experiences of different aspects of endometriosis healthcare, and the quality of that care. Aim: The aim of this thesis was to identify, describe and analyse the experiences, encounters and outcomes of endometriosis healthcare from different perspectives. Design and Method: This thesis is a summary of four studies with different methods and designs. Study I and II were qualitative interview studies in which nine women with a laparoscopy-verified endometriosis diagnosis (study I) and 25 healthcare professionals (HCPs) (study II) described their experiences of healthcare encounters related to endometriosis symptoms. The interviews were analysed using interpretive phenomenology (study I) and conventional content analysis (study II). Study III was a cross-sectional observational comparative study measuring pain thresholds, health-related quality of life (HRQoL) and symptoms of anxiety and depression using quantitative sensory testing (QST) and questionnaires in order to determine pain thresholds in healthy women (n=55) and women with persistent pelvic pain (PPP), with (n=14) and without (n=23) a confirmed diagnosis of endometriosis. The correlations between pain thresholds and duration of PPP, HRQoL and symptoms of anxiety and depression were also analysed. Study IV was a quantitative observational study using register data from the National Quality Register for Gynaecological Surgery. Patient-reported experience measures (PREM) and patient-reported outcome measures (PROM) after benign hysterectomy were analysed and compared in women with and without PPP and endometriosis (study IV). Results: The results of the thesis are summarized in three themes: The struggle to visualize the pain, The endometriosis diagnosis as a key to understanding and enduring persistent pelvic pain and Healthcare encounters as potentially life changing. In the first theme, women and HCPs described the healthcare encounters concerning endometriosis symptoms as troublesome (study I, II). The women struggled with disclosing, visualizing and communicating their hidden pain to the HCPs (study I), and HCPs expressed insecurity and limited knowledge when caring for these women (study II). Study III showed widespread reduced pain thresholds among women with PPP compared with healthy controls, and a significant positive correlation between duration of PPP and reduced pain thresholds . Study III also showed a reduced HRQoL and higher prevalence of anxiety and depressive symptoms among women with PPP, which were also described by the women (study I).The importance of getting a diagnosis was described in the second theme by both women and HCPs (study I, II), but women with PPP with and without endometriosis diagnosis did not differ significantly in their pain thresholds or psychosocial outcomes in study III. Likewise, women with PPP with and without endometriosis gave more equal PREM and PROM answers than women in the pain-free comparison group. Overall, women undergoing hysterectomy on benign indications were satisfied with the experience and outcomes of the surgery (study IV).As described in the last theme, healthcare encounters could be constructive or destructive. Positive experiences could make the symptoms easier to endure. The constructive encounters were often characterized by a holistic approach and a care structured in multidisciplinary teams. Conclusion and clinical implications: The results suggest that PPP should be taken seriously and treated actively in order to minimize the risk of physiological and psychological consequences, such as reduced pain thresholds, lower HRQoL and symptoms of anxiety and depression. Unrelieved PPP could also be an explanatory factor for long-term physiological consequences, such as lower PREM and PROM after hysterectomy.High-quality endometriosis healthcare should provide an interaction of physical, psychological and social factors. If women experience that HCPs acknowledge their pain and the effect of pain on HRQoL and mental health, and are offered proper pain-relieving treatment, healthcare encounters could change their lives.
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| 9. |
- Grundström, Hanna, 1982-, et al.
(author)
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Pain catastrophizing is associated with pain thresholds for heat, cold and pressure in women with chronic pelvic pain
- 2020
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In: Scandinavian Journal of Pain. - : WALTER DE GRUYTER GMBH. - 1877-8860 .- 1877-8879. ; 20:3, s. 635-646
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Journal article (peer-reviewed)abstract
- Background and aims: Psychological traits such as pain catastrophizing may play a role in the development of chronic pelvic pain (CPP). Pain catastrophizing is the tendency to amplify negative cognitive and emotional pain processes. The Pain Catastrophizing Scale (PCS) assesses elements of pain catastrophizing divided into three subgroups of factors (rumination, helplessness and magnification). Previous studies have shown associations between CPP and increased pain sensitivity, widespread generalized hyperalgesia, and decreased pain thresholds, but the relation between pain catastrophizing and specific pain thresholds has not yet been widely examined in this patient group. The aims of this study were (a) to determine if catastrophizing is increased in women with CPP compared with pain-free women, (b) to assess the importance of pain catastrophizing, psychological distress variables, and subjective pain sensitivity for pain thresholds of heat, cold and pressure in these two groups, and (c) to determine whether psychological variables or pain thresholds best contribute to the differentiation between CPP and controls. Methods: Thirty-seven women with chronic pelvic pain who underwent diagnostic laparoscopy on the suspicion of endometriosis participated along with 55 healthy and pain-free controls. All underwent quantitative sensory testing on six locations on the body to determine heat (HPT), cold (CPT) and pressure (PPT) pain thresholds. The PCS, the Pain Sensitivity Questionnaire (PSQ), the Hospital Anxiety Depression Scale, (HAUS) demographics and clinical data were collected prospectively. Principal component analysis and orthogonal partial least square regressions were used to assess the associations between PCS scores and pain thresholds. Results: The women with CPP scored significantly higher on PCS than the healthy controls. PCS-helplessness, PCS-rumination and HADS-depression were significantly associated with pain thresholds for the whole group. In the CPP group, PCS-rumination, body mass index and PSQ were significant regressors for HPT and CPT. The PCS and the HADS subscales were strongly intercorrelated in women with CPP and were stronger regressors of group membership than the three pain thresholds. In the group of healthy control women, no relationships were found to be significant. The psychological variables were somewhat stronger significant regressors than pain thresholds (also significant) for group membership. Conclusions: Women with CPP have significantly higher pain catastrophizing scores than women without CPP. The pain catastrophizing rumination factor is significantly associated with pain thresholds of heat and cold in CPP women. PCS and HADS are strongly intercorrelated and PSQ correlates positively with these variables. It seems that the psychological variables are important for group differentiation.
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| 10. |
- Grundström, Hanna, 1982-, et al.
(author)
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Reduced pain thresholds and signs of sensitization in women with persistent pelvic pain and suspected endometriosis
- 2019
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In: Acta Obstetricia et Gynecologica Scandinavica. - : John Wiley & Sons. - 0001-6349 .- 1600-0412. ; 98:3, s. 327-336
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Journal article (peer-reviewed)abstract
- INTRODUCTION: Endometriosis is a gynecological disorder that may cause considerable pelvic pain in women of fertile age. Determining pain mechanisms is necessary in order to optimize the treatment of the disease. The objective of the study was to evaluate pain thresholds in women with persistent pelvic pain with and without confirmed endometriosis, and healthy, unaffected controls, and analyze how pain thresholds in these cohorts related to duration of pelvic pain, quality of life, and symptoms of anxiety and depression.MATERIAL AND METHODS: Pain thresholds for heat, cold and pressure were assessed with quantitative sensory testing on six locations on a reference group of 55 healthy women and on 37 women with persistent pelvic pain who had been admitted for diagnostic laparoscopy on the suspicion of endometriosis. Validated instruments were applied to assess quality of life and symptoms of anxiety and depression. Data were analyzed by means of uni- and multivariate analysis of variance and Spearman's rank-order correlation.RESULTS: The women with persistent pelvic pain had significantly lower pain thresholds compared with the reference women. In the women with pain, no differences were observed in pain thresholds between women with (n = 13) and women without (n = 24) biopsy-proven endometriosis. The duration of pelvic pain correlated significantly positively with reduced pain thresholds, ie, the longer the duration, the more sensitization. In the persistent pelvic pain group, pain thresholds for heat correlated significantly with the Short Form Health Survey 36 dimension of bodily pain, and thresholds for cold correlated with Short Form Health Survey 36 bodily pain and with symptoms of depression.CONCLUSIONS: Our results showed widespread alterations in pain thresholds in women with persistent pelvic pain that are indicative of central sensitization and a time-dependent correlation. Women with pelvic pain and suspicion of endometriosis should probably be treated more thoroughly to prevent or at least minimize the concomitant development of central sensitization.
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| 11. |
- Hjerpe, Elisabet, et al.
(author)
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Lymph node metastases as only qualifier for stage IV serous ovarian cancer confers longer survival than other sites of distant disease - a Swedish Gynecologic Cancer Group (SweGCG) study.
- 2018
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In: Acta oncologica (Stockholm, Sweden). - : TAYLOR & FRANCIS LTD. - 1651-226X .- 0284-186X. ; 57:3, s. 331-337
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Journal article (peer-reviewed)abstract
- The International Federation of Gynecology and Obstetrics (FIGO) ovarian cancer staging system includes no sub-stage for lymph nodes (LN) as only distant disease manifestation. We explore the prognostic implication of LN as only stage IV classifier in serous ovarian cancer.This is a nation-wide, population-based study on 551 women with serous stage IV cancers diagnosed between 2009-2014. We compare overall survival (OS) in women with LN as only distant metastatic site to those with pleural metastases only and to patients with other/multiple stage IV manifestations. Cox regression models were used for uni- and multivariable estimations.Of 551stage IV cases, distant metastatic site was registered in 433. Median OS for women with LN (n=51) was 41.4 months, compared to 25.2 and 26.8 months for patients with pleural (n=195) or other/multiple (n=187) distant metastases (p=.0007). The corresponding five-year survival rates were 32, 11 and 22%, respectively. Multivariable analyzes confirmed shorter survival for women with pleural (HR 2.99, p=.001) or other/multiple distant sites (HR 2.67, p=.007), as compared to LN cases. LN only patients lived 9.1 months longer after primary than after interval surgery, but this difference was not significant (p=.245).Women with stage IV serous ovarian cancer having lymph nodes as only distant metastatic site live longer than other stage IV patients.
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| 12. |
- Karlsson, Anna, 1985-, et al.
(author)
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The effect of tinzaparin on biomarkers in FIGO stages III-IV ovarian cancer patients undergoing neoadjuvant chemotherapy – the TABANETOC trial: study protocol for a randomized clinical multicenter trial
- 2024
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In: Acta Oncologica. - Uppsala : Medical Journals Sweden. - 0284-186X .- 1651-226X. ; 63, s. 580-585
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Journal article (peer-reviewed)abstract
- Background: Tinzaparin, a low-molecular weight heparin (LMWH), has shown anti-neoplastic properties in animal models and in in vitro studies of human cancer cell lines. The reduction of CA-125 levels during neoadjuvant chemotherapy (NACT) in patients with epithelial ovarian cancer (EOC) co-varies with the prognosis; the larger the decrease in CA-125, the better the prognosis.Purpose: This study aims to evaluate the potential anti-neoplastic effects of tinzaparin by investigating changes in serum CA-125 levels in advanced EOC patients who receive NACT.Material and methods: This is an open randomized multicenter pilot trial. Forty patients with EOC selected to receive NACT will be randomized 1:1 to receive daily addition of tinzaparin or no tinzaparin. The processing and treatment of the patients will otherwise follow the recommendations in the Swedish National Guidelines for Ovarian Cancer. Before every cycle of chemotherapy, preoperatively, and 3 weeks after the last cycle of chemotherapy, a panel of biomarkers, including CA-125, will be measured.Patients: Inclusion criteria are women aged 18 years or older, World Health Organization performance status 0–1, histologically confirmed high-grade serous, endometrioid or clear cell EOC, International Federation of Gynecology and Obstetrics (FIGO) stages III-IV. In addition, a CA-125 level of ≥ 250 kIE/L at diagnosis. Exclusion criteria are contraindications to LMWH, ongoing or recent treatment with unfractionated heparin, LMWH, warfarin or non-vitamin K antagonist oral anticoagulants.Interpretation: This study will make an important contribution to the knowledge of the anti-neoplastic effects of tinzaparin in EOC patients and may thus guide the planning of a future study on the impact of tinzaparin on survival in EOC.
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| 13. |
- Kassymova, Gulnara, 1972-, et al.
(author)
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Effect of nurse-led telephone follow-up on postoperative symptoms and analgesics consumption after benign hysterectomy : a randomized, single-blinded, four-arm, controlled multicenter trial
- 2023
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In: Archives of Gynecology and Obstetrics. - : Springer Heidelberg. - 0932-0067 .- 1432-0711. ; 307:2, s. 459-471
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Journal article (peer-reviewed)abstract
- Purpose The study aimed to determine if planned telephone follow-up, especially when adding structured, oriented coaching, reduces the intensity of postoperative symptoms and decreases analgesics consumption after benign hysterectomy. Methods A randomized, single-blinded, four-armed, controlled multicenter trial of 525 women scheduled for hysterectomy was conducted in 5 hospitals in the southeast health region of Sweden. The women were allocated 1:1:1:1 into four follow-up models: (A) no telephone follow-up (control group); (B) one planned, structured, telephone follow-up the day after discharge; (C) as B but with additional telephone follow-up once weekly for 6 weeks; and (D) as C but with oriented coaching telephone follow-up on all occasions. Postoperative symptoms were assessed using the Swedish Postoperative Symptoms Questionnaire. Analgesic consumption was registered. Unplanned telephone contacts and visits were registered during the 6 weeks of follow-up. Results In total, 487 women completed the study. Neither pain intensity, nor symptom sum score or analgesic consumption differed between the intervention groups. Altogether, 224 (46.0%) women had unplanned telephone contacts and 203 (41.7%) had unplanned visits. Independent of intervention, the women with unplanned telephone contacts had higher pain intensity and symptom sum scores, particularly if an unplanned telephone contact was followed by a visit, or an unplanned visit was preceded by an unplanned telephone contact. Conclusion Telephone follow-up did not seem to affect recovery regarding symptoms or analgesic consumption after benign hysterectomy in an enhanced recovery after surgery (ERAS) setting. Unplanned telephone contacts and visits were associated with more postoperative symptoms, especially pain. Trial registration The study is registered in ClinicalTrial.gov: NCT01526668 retrospectively from January 27; 2012. Date of enrolment of first patient: October 11; 2011.
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| 14. |
- Kassymova, Gulnara, 1972-, et al.
(author)
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The Effect of Follow-Up Contact on Recovery After Benign Hysterectomy: A Randomized, Single-Blinded, Four-Arm, Controlled Multicenter Trial
- 2021
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In: Journal of Women's Health. - : MARY ANN LIEBERT, INC. - 1540-9996 .- 1931-843X. ; 30:6, s. 872-881
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Journal article (peer-reviewed)abstract
- Background: The objective of this trial was to analyze the effect of follow-up programs using standard follow-up protocol and structured coaching on recovery after hysterectomy in an enhanced recovery after surgery setting. Materials and Methods: A randomized, four-armed, single-blinded, controlled multicenter trial comprising 487 women was conducted at five hospitals in the southeast region of Sweden. The women were allocated (1:1:1:1) to Group A: no planned follow-up contact; Group B: a single, planned, structured, broadly kept, follow-up telephone contact with the research nurse the day after discharge; Group C: planned, structured, broadly kept follow-up telephone contact with the research nurse the day after discharge and then once weekly for 6 weeks; and Group D: as Group C, but with planned, structured, coaching telephone contact. Recovery was assessed by the health-related quality of life (HRQoL) questionnaires EuroQoL-5 Dimension with three levels (EQ-5D-3L) and Short-Form-Health Survey with 36 items (SF-36) and duration of sick leave. Results: Neither the recovery of HRQoL as measured by the EQ-5D-3L and the SF-36 nor the duration of sick leave (mean 26.8-28.1 days) differed significantly between the four intervention groups. Irrespective of mode of follow-up contact used, the women had recovered to their baseline EQ-5D-3L health index 4 weeks after surgery. The occurrence of unplanned telephone contact was significantly lower (by nearly 30%) in the women who had structured coaching. Conclusion: Follow-up contact, including coaching, did not seem to expedite the postoperative recovery in HRQoL or reduce the sick leave after hysterectomy, but the coaching seemed to reduce unplanned telephone contact with the health care services. ClinicalTrial.gov (NCT01526668).
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| 15. |
- Kassymova, Gulnara, 1972-
(author)
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The impact of postoperative telephone follow-up contacts on recovery after benign hysterectomy : with emphasis on health-related quality of life, postoperative symptoms, and health economics
- 2023
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Doctoral thesis (other academic/artistic)abstract
- BackgroundThe course of a postoperative recovery is important for both patient and healthcare services. Efforts to expedite and improve recovery in a safe and cost-effective manner are therefore highly desirable from the perspective of both parties. Telephone follow-up (TFU) has been suggested as a way to improve postoperative recovery and reduce the burden of the healthcare service. This thesis intends to investigate these issues. The overall purpose of the thesis was twofold: to evaluate the effects of nurse-led TFU contacts on the recovery after benign hysterectomy, and to make a health economic analysis of TFU. The specific aims of the thesis were a) to evaluate whether TFU, particularly when combined with structured-oriented coaching, facilitated postoperative recovery in terms of health-related quality of life (HRQoL), the duration of sick leave, and the occurrence of unplanned telephone contacts (uTCs) and unplanned visits (uVs) in the postoperative period, b) to determine if the TFUs affected postoperative symptoms and the consumption of analgesics, c) to analyze whether symptoms of anxiety and depression, and low stress-coping capacity had an impact on the effect of TFU on recovery and the occurrence of uTCs and uVs, and d) to provide a health economic evaluation of the TFU from the healthcare and societal perspectives. By addressing these aims, the intention of the thesis was to contribute with important knowledge to the existing sparse body of science concerning clinical outcomes after nurse-led TFUs and their impact on recovery outcomes after benign hysterectomy. Material and methodsA four-armed, semi-blinded, randomized controlled trial was conducted at the departments of obstetrics and gynecology in five public hospitals in the southeast health region of Sweden from October 2011 to May 2017. The study comprised 487 women between 18 and 60 years old who underwent abdominal or vaginal hysterectomy for benign gynecological conditions. The treatments to be investigated were different nurse-led TFU models and consisted of four groups: Group A had no planned follow-up contact with the healthcare service after discharge (control group); Group B had one planned, structured TFU session with the research nurse (RN) on the day after discharge; Group C had a planned, structured TFU session with the RN on the day after discharge and then once weekly for six weeks; and Group D had a planned, structured, oriented coaching TFU session with the RN on the day after discharge and then once weekly for six weeks. The specific content of the TFUs in Groups B and C, as well as the oriented coaching TFU model in Group D, were outlined in the study. Demographic and clinical data relevant to the study were collected prospectively. Sick leave duration, analgesic consumption, uTC, and uV were recorded from discharge until the six-week follow-up visit with the RN. HRQoL was measured by means of the EuroQoL-5 Dimension with three levels and the Short Form Health Survey with 36 items. Psychological distress was evaluated using the Hospital Anxiety and Depression Scale and the Stress-Coping Inventory. Postoperative symptoms were assessed using the Swedish Postoperative Symptoms Questionnaire. The health economics were evaluated using a cost minimization analysis. The estimation of hospital costs was based on the principles of the Cost Per Patient (CPP) method and the prices from the CPP list for 2022 from the University Hospital in Linköping were applied. ResultsRegardless of the TFU model, women achieved baseline levels of HRQoL four weeks after surgery and no difference was seen between the intervention groups in the trajectory of recovery of HRQoL. The duration of sick leave was similar across all intervention groups, ranging from 26.8 to 28.1 days. There were no significant differences in the trajectory of the intensity of postoperative symptoms or analgesic consumption between the intervention groups. Approximately 46% of the women had uTC and 45% had uV. The oriented coaching TFU was associated with a 33% lower occurrence of uTC compared with other TFU models. Women who had uTC reported higher levels of pain intensity and sum scores of postoperative symptoms, especially when the uTC was followed by a uV. Symptoms of depression, anxiety, and low stress coping capacity did not affect the effects of the TFU models on recovery trajectories, although there were strong associations between symptoms of anxiety, depression and low stress-coping capacity and all recovery measures. In addition, uTCs were more frequent among women with anxiety. The total costs per patient more than doubled in the groups with repeated TFUs compared with the group with no TFU. The coaching TFU group had lower costs for informal care. ConclusionsNurse-led TFU after benign hysterectomy in the form used in the present study did not expedite or improve the postoperative recovery concerning HRQoL, sick leave duration postoperative symptoms, or analgesic consumption. However, nurse-led TFU with structured coaching reduced the occurrence of uTC to healthcare providers, but not uVs. Symptoms of anxiety increased the occurrence of uTC and pain seemed to be a significant cause of both uTCs and uVs, The effect of the TFU on the recovery did not seem to be affected by the psychological state of proneness to anxiety, depression, or low stress-coping capacity. Nurse-led TFUs were cost-driving for the healthcare systems and can be seen as an inefficient use of healthcare resources.
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| 16. |
- Kjölhede, Preben, 1957-, et al.
(author)
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Abdominal urethrocystopexy using fibrin sealant. A prospective study of long-term efficacy
- 2000
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In: International Urogynecology Journal. - : Springer Science and Business Media LLC. - 0937-3462 .- 1433-3023. ; 11:2, s. 93-96
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Journal article (peer-reviewed)abstract
- Over the past decade efforts have been made to develop less invasive surgical treatment for female stress urinary incontinence (SUI). Abdominal urethrocystopexy with fibrin sealant combined with a couple of absorbable sutures has previously been reported as a promising method. This prospective observational study was aimed at evaluating the efficacy and safety of abdominal urethrocystopexy through a minilaparotomy using solely fibrin sealant (Tisseel) as the fixation glue. Forty-three women with objectively proven SUI were operated upon with this method. The subjective cure rates at 1 and 3 years' follow-up were 72% and 55%, respectively. The corresponding objective cure rates were 64% and 60%. No serious major operative complications occurred. One patient had transient urinary retention for 3 months. Otherwise, micturition was established within a median 1 day (range 1-3 days) after the operation. The result of this pilot study indicates a cure rate lower than that obtained with the conventional abdominal Burch colposuspension. Thus the method cannot be recommended as a standard procedure for treatment of SUI.
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| 17. |
- Kjölhede, Preben, 1957-, et al.
(author)
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Pelvic floor dysfunction after Burch colposuspension - A comprehensive study. Part I
- 2005
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In: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 84:9, s. 894-901
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Journal article (peer-reviewed)abstract
- Objective. To evaluate the occurrence of voiding dysfunction and symptoms of genital prolapse at long-term follow-up after Burch colposuspension (Bc) in relation to the occurrence of the symptoms in an age-matched normal population. Materials and methods. A follow-up study of the 190 patients who underwent Bc in 1980-88 and 305 age-matched control women randomly selected from the general population. The participants answered a questionnaire in 1998 with detailed questions about the pelvic floor function. Univariate and multivariate analyses were performed. Results. The prevalence and frequency of urinary incontinence were significantly higher in the patient group compared with those in the control group as were urge incontinence, difficulty to start voiding, time needed at the toilet for voiding, the need to return to the toilet for emptying the bladder, feeling of incomplete emptying of the bladder, and limitation of social life because of the leakage. The symptoms of genital prolapse were significantly more common in the patient group in spite of a significantly larger proportion of genital prolapse surgery in this group. Parity, high body mass index, heavy lifting work, chronic pulmonary diseases, hiatus hernias, and hysterectomy were significantly more common in the patient group than among the controls. Conclusions. At long-term follow-up, patients exhibit substantial symptoms of pelvic floor dysfunction (PFD) concerning voiding dysfunction and symptoms of genital prolapse compared with a normal population. This highlights the importance and need of treating pelvic floor disorders in a comprehensive way. Scientific works with comprehensive studies of PFD are needed. © Acta Obstet Gynecol Scand 2005.
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| 18. |
- Lukas, Peter, et al.
(author)
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Association Between Experimental Pain Thresholds and Trajectories of Postoperative Recovery Measures After Benign Hysterectomy
- 2022
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In: Journal of Pain Research. - : Dove Medical Press LTD. - 1178-7090. ; 15, s. 3657-3674
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Journal article (peer-reviewed)abstract
- Purpose: Quantitative sensory testing (QST) can be applied to quantify the sensitivity to different painful stimuli. This study aims to evaluate the association between preoperative pressure and thermal pain thresholds and trajectories of measurements of postoperative recovery (patient-reported daily maximum and average pain intensity, sum score of symptoms, and analgesic consumption) after benign hysterectomy.Patients and Methods: A prospective, longitudinal single-blinded, observational multicenter study was conducted in five hospitals in the southeast of Sweden between 2011 and 2017. A total of 406 women scheduled for abdominal or vaginal hysterectomy for benign conditions were enrolled in the study. QST measuring pressure (PPT), heat (HPT), and cold pain thresholds (CPT) were performed preoperatively. The cut-off levels for dichotomizing the pain thresholds (low/high) were set at the 25-percentile for PPT and HPT and the 75-percentile for CPT. The Swedish Postoperative Symptom Questionnaire was used to measure postoperative pain and other symptoms of discomfort (symptom sum score) on 13 occasions for six weeks postoperatively. Daily analgesic consumption of opioids and non-opioids was registered.Results: A CPT above the 75-percentile was associated with high postoperative maximum pain intensity (p = 0.04), high symptom sum score (p = 0.03) and greater consumption of non-opioids (p = 0.03). A HPT below the 25-percentile was only associated with greater consumption of non-opioids (p = 0.02). PPT was not associated with any of the outcome measures.Conclusion: CPT seemed to be predictive for postoperative pain and symptoms of discomfort after benign hysterectomy. Preoperative QST may be used to individualize the management of postoperative recovery for low pain threshold individuals.
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| 19. |
- Lundin, Evelyn, et al.
(author)
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A prospective randomized assessment of quality of life between open and robotic hysterectomy in early endometrial cancer
- 2019
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In: International Journal of Gynecological Cancer. - : BMJ Publishing Group Ltd. - 1048-891X .- 1525-1438. ; 29:4, s. 721-727
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Journal article (peer-reviewed)abstract
- Objective There are limited prospective data on the evaluation of quality of life in patients undergoing robotic hysterectomy for endometrial cancer. Our objective was to determine whether post-operative recovery differs between robotic and abdominal hysterectomy.Methods At a Swedish tertiary referral university hospital, 50 women with low-risk endometrial cancer scheduled for surgery between February 2012 and May 2016 were included in a randomized trial. Surgery was performed according to principles for minimal invasive surgery. Anesthesia and peri-operative care followed a standardized enhanced recovery after surgery program in both groups. The EuroQol Group form EQ-5D and the Short Form-36 were used to evaluate patients' health-related quality of life. The Swedish Postoperative Symptoms Questionnaire assessed symptoms pre-operatively, daily for 7 days from the day of surgery, and then weekly until 6 weeks post-operatively. Data were analyzed by means of non-parametric tests and repeated measures ANOVA. To evaluate the time-dependent occurrence of complications, Kaplan-Meier survival and Cox proportional-hazard models were used.Results A total of 50 women were enrolled in the study (25 robotic and 25 abdominal hysterectomy). Median age (68 years vs 67 years), estimated blood loss (50 mL vs 50 mL), length of hospital stay de facto (53 hours vs 51 hours), and time to meet discharge criteria (36 hours vs 36 hours) in the robotic and abdominal groups, respectively, did not differ significantly (p>0.05) Women in the robotic hysterectomy group recovered significantly faster (p=0.01) in the EQ-5D health index, and reached their pre-operative level after approximately 3 weeks, nearly 2 weeks earlier than the abdominal group. Differences regarding improvement in health-related quality of life (Short Form-36) were statistically significant in general health and social functioning only, and were in favor of robotic hysterectomy. Consumption of analgesics, pain intensity, and symptom sum score post-operatively were equal. Occurrence of complications was an independent risk factor and influenced significantly the EQ-5D health index, length of hospital stay, pain intensity, opioid consumption, and symptom sum score adversely.Conclusion Robotic hysterectomy in the setting of an enhanced recovery after surgery program led to faster recovery in health-related quality of life compared with abdominal hysterectomy.
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| 20. |
- Ramö Isgren, Anna, 1976-
(author)
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Maternal overweight and obesity : impact on obstetric outcomes in adolescents and oxytocin in labor
- 2021
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Doctoral thesis (other academic/artistic)abstract
- Objectives: The overall aim of this thesis was to evaluate the impact of maternal body mass index (BMI) on obstetric and neonatal outcomes in adolescents as well as on treatment with oxytocin infusion during labor regarding cumulative oxytocin dose and plasma levels of oxytocin.Material and Methods: Studies I and II were nationwide Swedish register studies including 31,386 primiparous adolescents subdivided in BMI groups and obesity classes according to early pregnancy BMI. Additionally, 178,844 low-risk normal weight adult women, called “the standard women” were included for comparison with the adolescents in the different BMI groups.Study III was an observational study conducted at seven maternity wards in the southeast region of Sweden, including 1,097 nulliparous women with spontaneous start of labor receiving oxytocin infusion during labor. The study group was subdivided according to BMI on admission to the labor ward. Cumulative oxytocin dose was registered from the start of the oxytocin infusion until the neonate was born. Study IV was an observational pilot study conducted at the maternity ward in Linköping, including 40 women in term labor receiving oxytocin infusion during the first stage of labor. The women were subdivided into obese and non-obese categories according to BMI on admission to the labor ward. Serial peripheral venous blood samples were taken during oxytocin infusion in the first stage of labor. The plasma oxytocin concentrations were analyzed with ultra performance liquid chromatography - Orbitrap tandem mass spectrometry at the Department of Chemistry Biomedical Centre, Uppsala University.Results: Compared with their normal weight counterparts and compared with the standard women, overweight and obese adolescents had increased risks for adverse pregnancy and neonatal outcomes such as preeclampsia, stillbirth, post-term pregnancy, neonates large for gestational age and neonates with low Apgar score. In labor, compared with the normal weight adolescents, the overweight and obese adolescents had a decreased chance for a normal vaginal delivery (VD), increased risk for Cesarean section (CS) and postpartum hemorrhage (PPH). However, compared with the standard women, the overweight adolescents had increased chance for a normal VD, and decreased risk for instrumental VD, CS, obstetric anal sphincter injury (OASI) and PPH in VD. The obese adolescents had an increased risk for CS but a decreased risk for instrumental VD and OASI and they had the same chance for a normal VD and no increased risk for PPH in VD.The mean cumulative oxytocin dose increased in the BMI groups (normal weight 2278 [2748] mU, overweight 3108 [3839] mU and obese 4082 [4895] mU (p<0.0001)) and the mean maximum oxytocin infusion rate during the first stage of labor was higher in the obese group compared with the overweight group of women (15.5 [9.5] mU/min vs. 13.6 [9.1] mU/min (p<0.05)). When adjusting for birth weight, epidural analgesia, and cervical dilation at the start of oxytocin infusion, the statistically significant differences were no longer seen. The obese women had increased median levels of oxytocin in plasma at an oxytocin infusion rate of 3.3 mU/min compared with the non-obese women (19.55 ng/mL [IQR 10.61; 29.06 ng/mL] vs. 6.97 ng/mL [IQR 5.55; 13.70 ng/mL], p=0.016).Conclusions: There are several adverse obstetric and neonatal outcomes associated with overweight and obesity in adolescents. It is important for clinicians to be aware of these outcomes in maternal health care. Nevertheless, overweight adolescents seemed to have better labor outcomes compared with low-risk adults, which is useful knowledge when risk-assessments are made in the labor ward.In spontaneous onset of labor, the cumulative oxytocin dose and maximum oxytocin infusion rate were higher in women with obesity compared with lower BMI groups. One explanatory factor seems to be that women with obesity received the oxytocin infusion at an earlier cervical dilatation stage. Furthermore, obese women seemed to have higher levels of oxytocin in plasma at the beginning of the oxytocin infusion. The oxytocin-oxytocin receptor complex must be further investigated to gain more knowledge on how to optimize the treatment of obese women with oxytocin infusion during labor.
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| 21. |
- Rosenberg, Per, et al.
(author)
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Data quality in the Swedish Quality Register of Gynecologic Cancer - a Swedish Gynecologic Cancer Group (SweGCG) study
- 2018
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In: Acta Oncologica. - : TAYLOR & FRANCIS LTD. - 0284-186X .- 1651-226X. ; 57:3, s. 346-353
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Journal article (peer-reviewed)abstract
- Aim: The aim of this study is to evaluate the quality of data on endometrial (EC) and ovarian, fallopian tube, peritoneal, abdominal or pelvic cancers (OC) registered in the Swedish Quality Register of Gynecologic Cancer (SQRGC).Method: A random sample of 500 patients was identified in the SQRGC and their medical charts were reviewed for re-abstraction of 31 selected core variables by an independent validator. The data in the SQRGC and the re-abstracted data were compared. The data were collected from 25 hospitals evenly distributed throughout Sweden. The main outcomes were comparability, timeliness, completeness and validity. Coverage was compared with the National Cancer Register (NCR). Timeliness was defined as the speed of registration i.e. when patients were registered in the SQRGC relative to date of diagnosis. Internationally accepted coding systems for stage, grading and histologic type were used ensuring a high degree of comparability. Correlations were estimated using Pearson’s correlation coefficient and Cohen´s kappa coefficient.Results: The completeness was 95%. The timeliness was 88–91% within 12 months of diagnosis. The median degree of agreement between re-abstracted data and data in the SQRGC was 82.1%, with a median kappa value of 0.73 for ordinate variables and a median Pearson’s correlation coefficient of 0.96. The agreements for the type of surgery were 76% (95% CI 70–81%; kappa 0.49) and type of primary treatment 90% (95% CI 87–94%; kappa 0.85) in OC and in EC 88% (95% CI 84–93%; kappa 0.84). The agreements for the FIGO stage were in OC and EC 74% (95% CI 68–80%; kappa 0.69) and 87% (95% CI 82–91%; kappa 0.79), respectively.Conclusions: The data in the Swedish Quality Register for Gynecologic Cancer are of adequate quality in order to be used as a basis for research and to evaluate possible differences in treatment, lead times and treatment results.
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| 22. |
- Serreyn Lundin, Evelyn, 1969-
(author)
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On Quality Improvement in Gynaecological Cancer Surgery
- 2020
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Doctoral thesis (other academic/artistic)abstract
- Objectives: The overall purpose of this thesis was to find medical and surgical treatment methods of improving the perioperative care of gynaecological cancer patients. The specific objectives were to determine whether a single dose tranexamic acid given immediately before surgery for presumed advanced ovarian cancer reduces perioperative blood loss and the need for blood transfusions, and to determine whether postoperative recovery, tissue damage, and inflammatory response markers differ between women operated with robotic and abdominal hysterectomy for low-risk endometrial cancer in an enhanced recovery after surgery (ERAS) programme, and to evaluate costs for hospital stay and postoperative recovery in relation to health impact. Material and Methods: The thesis was based on two randomised trials. The first trial was a randomised double-blind placebo-controlled multicentre study conducted in four hospitals in the southeast and central of Sweden between March 2008 and May 2012. One hundred women with presumed advanced ovarian cancer who had been scheduled for radical debulking surgery were included; 50 received tranexamic acid and 50 received a placebo. The main outcomes were blood loss and red blood cell transfusions. The second trial was a randomised open single centre trial at a Swedish university hospital, which included 50 women with low-risk endometrial cancer scheduled for radical surgery between February 2012 and May 2016; 25 women underwent robotic hysterectomy and 25 had abdominal hysterectomy. Anaesthesia and perioperative care followed an ERAS protocol in both groups. The EuroQol Group form EQ-5D-3L and the Short Form-36 evaluated the health-related quality of life. The Swedish Postoperative Symptoms Questionnaire assessed symptoms perioperatively until six weeks postoperatively. Venous blood samples were collected on several occasions until six weeks postoperatively and were analysed for markers reflecting inflammatory response and tissue damage. In addition, a health economic evaluation was conducted comparing total costs, qualityadjusted life years (QALYs) and cost per QALY between the surgical methods. Results: Total blood loss volume and transfusion rate following surgery in advanced ovarian cancer were significantly lower in the tranexamic group compared with the placebo group. Women with early endometrial cancer treated by robotic hysterectomy recovered significantly faster in the EQ-5D health index, and reached their preoperative level nearly two weeks earlier than the abdominal group. Differences regarding improvement in health-related quality of life (Short Form-36) comprising general health and social functioning were more favourable in the robotic hysterectomy group. Consumption of analgesics, pain intensity, postoperative symptom sum score and length of hospital stay were equal between the groups. The occurrence of complications was an independent risk factor and influenced most of the outcome measures adversely. Postoperative inflammatory response and tissue damage were lower after robotic hysterectomy compared with the abdominal approach. The robotic group gained more QALYs until six weeks after surgery than the abdominal group but the total costs were higher. The total cost per QALY gained was quite high for the robotic procedure. Conclusions: A single dose of tranexamic acid given immediately before surgery reduces blood loss and transfusion rates in advanced ovarian cancer surgery. Robotic hysterectomy in an ERAS programme treating early endometrial cancer leads to a faster recovery in the health-related quality of life than abdominal hysterectomy, the latter being strongly influenced by perioperative complications. Less tissue damage and inflammation might contribute to a faster recovery in the robotic group. Robotic hysterectomy provides more QALYs until six weeks postoperatively but with a substantially higher total cost for the society.
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| 23. |
- Stålberg, Karin, et al.
(author)
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Risk factors for lymph node metastases in women with endometrial cancer: A population-based, nation-wide register study - On behalf of the Swedish Gynecological Cancer Group
- 2017
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In: International Journal of Cancer. - : Wiley. - 0020-7136 .- 1097-0215. ; 140:12, s. 2693-2700
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Journal article (peer-reviewed)abstract
- The role of lymphadenectomy in the management of early endometrial cancer remains controversial. In the recent ESMO-ESGO-ESTRO guidelines, lymphadenectomy is recommended for patients with endometrioid adenocarcinoma Grade 3 with deep myometrial invasion, but complete agreement was not achieved. In Sweden, DNA aneuploidy has been included as a high-risk factor. The aim of our study was to evaluate the impact of tumor histology, FIGO grade, DNA ploidy and myometrial invasion (MI) on occurrence of lymph node metastasis (LNM) in patients with endometrial cancer. The study design is a retrospective cohort study based on prospectively recorded register data. Endometrial cancer patients registered in the Swedish Quality Registry for Gynecologic Cancer 2010-2015 with FIGO Stages I-III and verified nodal status were included. Data on DNA ploidy, histology, FIGO grade and MI were included in multivariable log-binomial regression analyses with LNM as dependent variable. 1,165 cases fulfilled the inclusion criteria. The multivariable analyses revealed increased risk of LNM in patients with tumors with MI50% (risk ratio [RR]=4.1; 95% confidence interval [CI] 3.0-5.6), nonendometrioid compared to endometrioid histology (RR 1.8; CI 1.4-2.4) and FIGO Grade 3 compared to Grade 1-2 tumors (RR 1.5; CI 1.1-2.0). No statistically significant association between DNA ploidy status and LNM was detected. This population-based, nation-wide study in women with endometrial cancer confirms a strong association between MI50%, nonendometrioid histology and FIGO Grade 3, respectively, and LNM. DNA ploidy should not be included in the preoperative decision making of removing nodes or not. What's new? Whether lymphadenectomy is beneficial for women with endometrial cancer remains uncertain. Moreover, additional studies are needed to explore factors that reliably predict lymph node metastasis (LNM). Here, multiple factors, including tumor histology, grade of differentiation and DNA aneuploidy, were evaluated for associations with LNM risk in women with endometrial cancer and verified lymph node status. Most significantly, deep myometrial invasion in tumors increased LNM risk fourfold, whereas DNA ploidy had essentially no impact on LNM risk. The findings confirm the predictive relevance of myometrial invasion, histology and grade reported in previous single-center and multicenter studies.
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| 24. |
- Uustal Fornell, Eva, 1960-, et al.
(author)
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Factors associated with pelvic floor dysfunction with emphasis on urinary and fecal incontinence and genital prolapse : an epidemiological study
- 2004
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In: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 83:4, s. 383-389
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Journal article (peer-reviewed)abstract
- Objective. To describe a general population of women with regard to factors associated with urinary and fecal incontinence and genital prolapse symptoms.Methods. A questionnaire about medical background, urinary and fecal incontinence and genital prolapse symptoms was mailed to 1000 40-year-old and 1000 60-year-old Swedish women. Associations were described by odds ratios (ORs) with 95% confidence intervals (CIs).Results. Sixty-seven percent answered the questionnaire. Multivariate analysis showed urinary incontinence to be associated with anal sphincter rupture [OR 4.4 (95% CI 1.0–18.8)], pelvic heaviness [3.8 (2.1–7.0)], body mass index (BMI) ≥30 kg/m2[3.7 (2.0–6.7)], multiparity [1.8 (1.0–3.4)], varicose veins surgery [1.9 (1.2–3.2)] and age [1.9 (1.2–3.2)]. Univariate analyses revealed statistically significant associations between urinary incontinence and incontinence for flatus [4.8 (3.0–7.8)], for liquid stool [5.0 (2.9–8.6)] and for solid stool [5.9 (2.4–14.2)]. Chronic bronchitis [5.7 (1.7–18.9)] was strongly associated with urinary incontinence but was only reported by the older age group. Prolapse symptoms were strongly associated with both urinary and fecal incontinence. Prolapse symptoms as opposed to urinary and fecal incontinence seemed to be associated more with injuries at delivery than with chronic pelvic floor strain.Conclusions. Women with urinary incontinence are also likely to suffer from fecal incontinence and prolapse and vice versa. Other associated factors for pelvic floor dysfunction were overweight, and especially obesity, chronic bronchitis, vaginal delivery and multiparity, age, heredity and diseases suggestive of collagen disorders. A multidisciplinary management of women with pelvic floor symptoms is suggested and possible prevention is discussed.
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| 25. |
- Uustal Fornell, Eva, 1960-, et al.
(author)
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Prevalence of urinary and fecal incontinence and symptoms of genital prolapse in women
- 2003
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In: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 82:3, s. 280-286
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Journal article (peer-reviewed)abstract
- Background. Urinary incontinence is common in women. How often incontinence occurs has been only briefly investigated. Studies on the prevalence of fecal incontinence are few. The epidemiology of genital prolapse symptoms is unknown. This epidemiological study describes a general population of women aged 40 and 60 years with regard to the prevalence and frequency of urinary and fecal incontinence and the prevalence of genital prolapse symptoms.Methods. A questionnaire on medical background, urinary and fecal incontinence, and genital prolapse symptoms was sent to 1000 40-year-old and 1000 60-year-old randomly selected women.Results. Sixty-seven per cent answered: 53% were continent for urine; 9% of the 40-year-olds and 19% of the 60-year-olds had urinary incontinence weekly or more often. Detrusor instability score was significantly higher in the 60-year-olds. Incontinence of flatus, weekly or more often, was reported by 9% and 19%, loose feces by 5% and 8%, and solid feces by 0.3% and 1.7% according to the 40- and 60-year-olds, respectively. Fifty-three per cent reported no flatus incontinence. Of the prolapse symptoms investigated, 15% of the females reported pelvic heaviness, 4% genital bulge, and 12% use of fingers in the vagina or perineum by defecation.Conclusions. Incontinence of urine is common in this population. Flatus incontinence is as common, but the concept must be operationalized if used as an endpoint in research. The International Continence Society's (ICS) definition of urinary incontinence is unpractical for use in epidemiological research. We suggest leakage weekly or more often as a criterion for significant incontinence in epidemiological research.
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| 26. |
- Wedin, Madelene, 1976-
(author)
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On lymphedema of the lower limbs after treatment of endometrial cancer : with emphasis on incidence, quality of life, risk factors, and health economy
- 2021
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Doctoral thesis (other academic/artistic)abstract
- Objectives: The overall purpose of this study was to investigate the long-term consequences of primary surgical treatment of endometrial cancer with emphasis on lymphadenectomy, lymphedema development in the limbs, health-related quality of life, and health economy aspects. The primary objective was to assess the incidence of lymphedema both objectively and subjectively by using three different methods to determine lymphedema. Secondary objectives were to determine risk factors for lymphedema, and to analyze the impact of lymphadenectomy and lymphedema on health-related quality of life. Another secondary objective was to evaluate the hospital costs of lymphadenectomy and lymphedema one year after primary treatment of endometrial cancer.Material and methods: The study was a prospective observational longitudinal multicenter study with 15 Swedish hospitals participating between June 2014 and January 2018. Two hundred sixty-two women with presumed early stage endometrial cancer were included; 235 women completed the study. Of these, 119 were classified as having high-risk endometrial cancer and underwent surgery including lymphadenectomy, and 116 were classified as having low-risk endometrial cancer where no lymphadenectomy was performed. The women were evaluated preoperatively according to the national guidelines for endometrial cancer. The women were all monitored on four occasions: preoperatively, then four to six weeks, six months, and one year postoperatively. On all occasions, lymphedema was evaluated by means of two objective methods: systematic circumferential measurements of the lower limbs, enabling estimation of the leg volume, and by clinical grading of lymphedema of the lower limbs, and subjectively by means of the patient-reported perception of leg swelling. Health-related quality of life was evaluated using three different quality of life questionnaires. Two were generic: the SF-36 and EQ-5D-3L, and one was lymphedema-specific: the LYMQOL. Intraabdominal lymphocysts were evaluated by transvaginal ultrasound. Cost analysis of hospital costs was performed in relation to lymphadenectomy and lymphedema development.Results: The incidence of lymphedema varied between 9.5% and 29.6%, depending on the method of assessment of lymphedema. The highest incidence was found when using patient-reported swelling. The incidences of lymphedema were significantly higher in the lymphadenectomy group (14.9% - 38.1%) compared with the non-lymphadenectomy group (3.4% - 21.4%). The inter-rater agreement of lymphedema between the various methods of determining lymphedema was low. The incidence of lymphocysts was 4.3% and did not seem to pose a clinical problem. Lymphadenectomy per se did not seem to affect health-related quality of life negatively; however, lymphedema, independent of the method of assessing lymphedema, affected the lymphedema-specific quality of life significantly negatively, mainly in physical domains. Lymphadenectomy, age, and adjuvant radiation therapy were independent risk factors for lymphedema. Lymphadenectomy generated higher hospital costs, independent of the mode of surgery.Conclusions: A significant number of women develop lymphedema after lymphadenectomy in the treatment of endometrial cancer. The incidences vary, depending on the method of determining lymphedema. This inconsistency is also reflected in risk factors for lymphedema. Lymphadenectomy, increasing age, and adjuvant radiation are factors to pay attention to when planning treatment of endometrial cancer, not least because lymphedema has a negative impact on health-related quality of life. Lymphadenectomy is a cost-driving procedure and its use should be carefully evaluated in relation to its potential benefits.
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| 27. |
- Wedin, Madelene, 1976-, et al.
(author)
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Risk factors for lymphedema and method of assessment in endometrial cancer: a prospective longitudinal multicenter study
- 2021
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In: International Journal of Gynecological Cancer. - : BMJ. - 1048-891X .- 1525-1438. ; 31:11, s. 1416-1427
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Journal article (peer-reviewed)abstract
- Objective The aim of the study was to determine risk factors for lymphedema of the lower limbs, assessed by four methods, 1 year after surgery for endometrial cancer. Methods A prospective longitudinal multicenter study was conducted in 14 Swedish hospitals. 235 women with endometrial cancer were included; 116 underwent surgery including lymphadenectomy, and 119 had surgery without lymphadenectomy. Lymphedema was assessed preoperatively and 1 year postoperatively objectively by systematic circumferential measurements of the legs, enabling volume estimation addressed as (1) crude volume and (2) body mass index-standardized volume, or (3) clinical grading, and (4) subjectively by patient-reported perception of leg swelling. In volume estimation, lymphedema was defined as a volume increase >= 10%. Risk factors were analyzed using forward stepwise logistic regression models and presented as adjusted odds ratio (aOR) and 95% confidence interval (95% CI). Results Risk factors varied substantially, depending on the method of determining lymphedema. Lymphadenectomy was a risk factor for lymphedema when assessed by body mass index-standardized volume (aOR 14.42, 95% CI 3.49 to 59.62), clinical grading (aOR 2.11, 95% CI 1.04 to 4.29), and patient-perceived swelling (aOR 2.51, 95% CI 1.33 to 4.73), but not when evaluated by crude volume. Adjuvant radiotherapy was only a risk factor for lymphedema when assessed by body mass index-standardized volume (aOR 15.02, 95% CI 2.34 to 96.57). Aging was a risk factor for lymphedema when assessed by body mass index-standardized volume (aOR 1.07, 95% CI 1.00 to 1.15) and patient-perceived swelling (aOR 1.06, 95% CI 1.02 to 1.10), but not when assessed by crude volume or clinical grading. Increase in body mass index was a risk factor for lymphedema when estimated by crude volume (aOR 1.92, 95% CI 1.36 to 2.71) and patient-perceived swelling (aOR 1.36, 95% CI 1.11 to 1.66), but not by body mass index-standardized volume or clinical grading. The extent of lymphadenectomy was strongly predictive for the development of lymphedema when assessed by body mass index-standardized volume and patient-perceived swelling, but not by crude volume or clinical grading. Conclusion Apparent risk factors for lymphedema differed considerably depending on the method used to determine lymphedema. This highlights the need for a 'gold standard' method when addressing lymphedema for determining risk factors.
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- Zach, Diana, et al.
(author)
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Can we extend the indication for sentinel node biopsy in vulvar cancer? A nationwide feasibility study from Sweden
- 2019
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In: International Journal of Gynecological Cancer. - : BMJ. - 1048-891X .- 1525-1438.
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Journal article (peer-reviewed)abstract
- Background: In squamous cell vulvar cancer, sentinel node biopsy is accepted as standard treatment in well-defined patient groups and has reduced surgical morbidity considerably. Currently, due to the lack of evidence, it cannot be offered to patients with tumors of 4 cm diameter or greater or with multifocal tumors, or in local recurrences. Primary objective: This study is primarily a pilot and feasibility trial, aiming to evaluate if the prerequisites concerning detection rate and negative predictive value are satisfactory before the implementation of a multinational trial. Study hypothesis: Sentinel node biopsy has an acceptable negative predictive value and detection rate in the study cohort. Trial design: This study is planned as a prospective, national, multicenter interventional trial. Participating patients will undergo a sentinel node biopsy in addition to an inguinofemoral lymphadenectomy. Inclusion and exclusion criteria: Inclusion criteria: for women in group 1, a primary tumor ≥4 cm in diameter; in group 2, a multifocal primary tumor; in group 3, a local recurrence without previous inguinofemoral lymphadenectomy or radiation to the groins; in group 4, a local recurrence, with previous inguinofemoral lymphadenectomy and/or radiation to the groins. Primary endpoint: The primary endpoints are the detection rate and the negative predictive value of the sentinel node procedure. Sample size: In each of the four study arms, recruitment of 20-30 patients is planned. Estimated dates for completing recruitment and presenting results: Recruitment will take place between November 2019 and October 2021. Results will be available in December 2021.
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