| 1. |
- Falconer, Henrik, et al.
(författare)
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Robot-assisted approach to cervical cancer (RACC) : an international multi-center, open-label randomized controlled trial
- 2019
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Ingår i: International Journal of Gynecological Cancer. - : BMJ Publishing Group Ltd. - 1048-891X .- 1525-1438. ; 29:6, s. 1072-1076
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Tidskriftsartikel (refereegranskat)abstract
- Background: Radical hysterectomy with pelvic lymphadenectomy represents the standard treatment for early-stage cervical cancer. Results from a recent randomized controlled trial demonstrate that minimally invasive surgery is inferior to laparotomy with regards to disease-free and overall survival.Primary Objective: To investigate the oncologic safety of robot-assisted surgery for early-stage cervical cancer as compared with standard laparotomy.Study Hypothesis: Robot-assisted laparoscopic radical hysterectomy is non-inferior to laparotomy in regards to recurrence-free survival with the advantage of fewer post-operative complications and superior patient-reported outcomes.Trial Design: Prospective, multi-institutional, international, open-label randomized clinical trial. Consecutive women with early-stage cervical cancer will be assessed for eligibility and subsequently randomized 1:1 to either robot-assisted laparoscopic surgery or laparotomy. Institutional review board approval will be required from all participating institutions. The trial is coordinated from Karolinska University Hospital, Sweden.Major Inclusion/Exclusion Criteria: Women over 18 with cervical cancer FIGO (2018) stages IB1, IB2, and IIA1 squamous, adenocarcinoma, or adenosquamous will be included. Women are not eligible if they have evidence of metastatic disease, serious co-morbidity, or a secondary invasive neoplasm in the past 5 years.Primary Endpoint: Recurrence-free survival at 5 years between women who underwent robot-assisted laparoscopic surgery versus laparotomy for early-stage cervical cancer.Sample Size: The clinical non-inferiority margin in this study is defined as a 5-year recurrence-free survival not worsened by >7.5%. With an expected recurrence-free survival of 85%, the study needs to observe 127 events with a one-sided level of significance (alpha) of 5% and a power (1-beta) of 80%. With 5 years of recruitment and 3 years of follow-up, the necessary number of events will be reached if the study can recruit a total of 768 patients.Estimated Dates for Completing Accrual and Presenting Results: Trial launch is estimated to be May 2019 and the trial is estimated to close in May 2027 with presentation of data shortly thereafter.
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| 2. |
- Razumova, Zoia, et al.
(författare)
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Report from the European Society of Gynaecological Oncology (ESGO) 2020 State-of-the-Art Virtual Meeting
- 2021
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Ingår i: International Journal of Gynecological Cancer. - : BMJ. - 1048-891X .- 1525-1438. ; 31:5, s. 658-669
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Tidskriftsartikel (refereegranskat)abstract
- This is a report from the European Society of Gynaecological Oncology State-of-the-Art Virtual Meeting held December 14-16, 2020. The unique 3-day conference offered comprehensive state-of-the-art summaries on the major advances in the treatment of different types of gynecological cancers. Sessions opened with a case presentation followed by a keynote lecture and interactive debates with opinion leaders in the field. The speakers also presented scientific reviews on the clinical trial landscape in collaboration with the European Network of Gynecological Oncological Trial (ENGOT) groups. In addition, the new ESGO-ESRTO-ESP endometrial cancer guidelines were officially presented in public. This paper describes the key information and latest studies that were presented for the first time at the conference.
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| 3. |
- Andrada Hamar, Maria, et al.
(författare)
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Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur
- 2011
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Ingår i: International Urogynecology Journal. - : Springer. - 0937-3462 .- 1433-3023. ; 22:7, s. 781-787
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Tidskriftsartikel (refereegranskat)abstract
- Introduction and hypothesis: The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety.Methods: We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up.Results: No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p < 0.0001).Conclusions: In a prospective randomized controlled study, the TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.
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| 4. |
- Persson, Jan
(författare)
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Stress urinary incontinence among women. Aspects of risk factors, evaluation and surgical treatment.
- 2001
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- The etiology of female stress urinary incontinence (SUI) is unclear. By linking three nationwide medical registries we evaluated maternal and obstetric factors associated with later SUI surgery. Surgery for SUI was strongly associated with vaginal delivery, but not with pregnancy as such. Maternal conditions and interventions during delivery modified the association. Proper evaluation of treatment of SUI requires an objective outcome measure. In an experimental study we found a novel ultrashort perineal pad-test to sufficiently meet with requirements for such a test in terms of reproducibility and feasibility. During recent years less invasive modifications of traditional surgical methods for SUI have been introduced. In two prospective studies on laparoscopic colposuspension, objective outcome, urodynamic correlates, and suturing techniques were assessed. Short term cure rate was 82% and 83% respectively when 2 sutures were used on each side of the urethra. Women randomized to one suture on each side of the urethra had significantly lower cure rate (59%). Short preoperative urethral functional length was associated with failure. In a retrospective case control study, we wanted to identify variables associated with rejection of synthetic suburethral slings used for SUI surgery. Rejection was independently and negatively associated with appropriate antibiotic prophylaxis and with the surgeon performing the operation. In a prospective randomized study, total cost to the county (hospital owner) for Tension-free Vaginal Tape (TVT) was found higher than for laparoscopic colposuspension. The charges for anesthesia time and the investment cost for the disposable TVT kit were the most cost deciding factors
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| 5. |
- Qvist, Ninni, et al.
(författare)
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From being restrained to recapturing vitality : non-western immigrant women's experiences of undergoing vitamin D treatment after childbirth
- 2019
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Ingår i: International Journal of Qualitative Studies on Health and Well-being. - : Informa UK Limited. - 1748-2623 .- 1748-2631. ; 14:1
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: Vitamin D deficiency is a complex topic in human health and ill-health and has been studied in a variety of contexts and populations. Few studies examine Vitamin D deficiency among non-western immigrant women and even fewer examine women's perspective on daily life while living with low vitamin D levels after childbirth and undergoing vitamin D treatment. The aim was, therefore, to explore health and ill-health among non-western immigrant women living with low vitamin D levels after childbirth and reaching normalized levels after one year of vitamin D treatment.Method: An explorative qualitative study using qualitative content analysis. Six women aged 25 to 38 years, diagnosed with low 25-hydroxyvitamin D levels during pregnancy, were recruited after having undergone vitamin D treatment.Results: The women told about living a restrained life which gradually transformed into an experience of recaptured vitality. They also experienced a need for continuity in medication, as an interruption of treatment meant returning symptoms.Conclusion: In this study, non-western immigrant women described benefits in everyday life, increased strength, relieved pain and improved sleep quality. The findings can provide valuable knowledge for healthcare providers meeting women with physical weakness, musculoskeletal pain and/or poor sleep quality after childbirth. Further studies using a longitudinal design and larger samples are warranted.
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| 6. |
- Alfonzo, Emilia, et al.
(författare)
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No survival difference between robotic and open radical hysterectomy for women with early-stage cervical cancer: results from a nationwide population-based cohort study
- 2019
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Ingår i: European Journal of Cancer. - : Elsevier BV. - 0959-8049 .- 1879-0852. ; 116, s. 169-177
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: The aim of the study was to compare overall survival (OS) and disease-free survival (DFS) after open and robotic radical hysterectomy for early-stage cervical cancer. Patients and methods: This was a nationwide population-based cohort study on all women with cervical cancer stage IA1-IB of squamous, adenocarcinoma or adenosquamous histological subtypes, from January 2011 to December 2017, for whom radical hysterectomy was performed. The Swedish Quality Register of Gynaecologic Cancer was used for identification. To ensure quality and conformity of data and to disclose patients not yet registered, hospital registries were reviewed and validated. Cox and propensity score regression analysis and univariable and multivariable regression analysis were performed in regard to OS and DFS. Results: There were 864 women (236 open and 628 robotic) included in the study. The 5-year OS was 92% and 94% and DFS was 84% and 88% for the open and robotic cohorts, respectively. The recurrence pattern was similar in both groups. Using propensity score analysis and matched cohorts of 232 women in each surgical group, no significant differences were seen in survival: 5-year OS of 92% in both groups (hazard ratio [HR], 1.00; 95% confidence interval [CI], 0.50–2.01) and DFS of 85% vs 84% in the open and robotic cohort, respectively (HR, 1.08; 95% CI, 0.66–1.78). In univariable and multivariable analysis with OS as the end-point, no significant factors were found, and in regard to DFS, tumour size (p < 0.001) and grade 3 (p = 0.02) were found as independent significant risk factors. Conclusion: In a complete nationwide population-based cohort, where radical hysterectomy for early-stage cervical cancer is highly centralised, neither long-term survival nor pattern of recurrence differed significantly between open and robotic surgery. © 2019 The Authors
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| 7. |
- Ekdahl, Linnea, et al.
(författare)
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Long term oncologic and reproductive outcomes after robot-assisted radical trachelectomy for early-stage cervical cancer. An international multicenter study
- 2022
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Ingår i: Gynecologic Oncology. - : Elsevier BV. - 0090-8258 .- 1095-6859. ; 164:3, s. 529-534
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: Long term outcomes following fertility sparing robot-assisted radical trachelectomy (RRT). Methods: A retrospective study of consecutive women selected for RRT between 2007 and 2019 at five referral centres. Generally used selection criteria for fertility-sparing surgery were applied. Oncologic, reproductive and long-term clinical data were analysed. Results: Of the 166 included women, 149 completed a RRT. Median tumor size was 9 mm (range 3-20 mm), 111 women (75%) had FIGO 2009 stage IB1 cancer and 4.8% were node positive. At a median follow up of 58 months, 12 of all women (7.2%) and 9 of 149 women (6%) who underwent completed RRT with fertility preservation had recurred and two had died. 70 of 88 women (80%) who attempted to conceive succeeded, resulting in 81 pregnancies that progressed beyond the first trimester and 76 live births of which 54 (70%) were delivered at term and 65 (86%) delivered after gestational week 32. A short postoperative cervical length was associated with impaired fertility. A late secondary hysterectomy was necessary in four women due to persistent bleeding (n = 2), hematometra due to a cervical stenosis (n = 1) and recurrent dysplasia (n = 1). Conclusion: In this long-term follow-up of RRT the recurrence rate is comparable to larger individual studies of minimally invasive or vaginal radical trachelectomy with similar risk profile and follow up. The high pregnancy rate and low rate of premature delivery before 32 weeks GA may promote the use of robot-assisted approach.
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| 8. |
- Geppert, Barbara, et al.
(författare)
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Sentinel lymph node biopsy in endometrial cancer-Feasibility, safety and lymphatic complications
- 2018
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Ingår i: Gynecologic Oncology. - : Elsevier BV. - 0090-8258. ; 148:3, s. 491-498
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To compare the rate of lymphatic complications in women with endometrial cancer undergoing sentinel lymph node biopsy versus a full pelvic and infrarenal paraaortic lymphadenectomy, and to examine the overall feasibility and safety of the former. Methods: A prospective study of 188 patients with endometrial cancer planned for robotic surgery. Indocyanine green was used to identify the sentinel lymph nodes. In low-risk patients the lymphadenectomy was restricted to removal of sentinel lymph nodes whereas in high-risk patients also a full lymphadenectomy was performed. The impact of the extent of the lymphadenectomy on the rate of complications was evaluated. Results: The bilateral detection rate of sentinel lymph nodes was 96% after cervical tracer injection. No intraoperative complication was associated with the sentinel lymph node biopsy per se. Compared with hysterectomy alone, the additional average operative time for removal of sentinel lymph nodes was 33. min whereas 91. min were saved compared with a full pelvic and paraaortic lymphadenectomy. Sentinel lymph node biopsy alone resulted in a lower incidence of leg lymphedema than infrarenal paraaortic and pelvic lymphadenectomy (1.3% vs 18.1%, p = 0.0003). Conclusion: The high feasibility, the absence of intraoperative complications and the low risk of lymphatic complications supports implementing detection of sentinel lymph nodes in low-risk endometrial cancer patients. Given that available preliminary data on sensitivity and false negative rates in high-risk patients are confirmed in further studies, we also believe that the reduction in lymphatic complications and operative time strongly motivates the sentinel lymph node concept in high-risk endometrial cancer.
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| 9. |
- Johansen, Gry, et al.
(författare)
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Reproductive and oncologic outcome following robot-assisted laparoscopic radical trachelectomy for early stage cervical cancer.
- 2016
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Ingår i: Gynecologic Oncology. - : Elsevier BV. - 1095-6859 .- 0090-8258.
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Tidskriftsartikel (refereegranskat)abstract
- Objective To investigate the reproductive and oncologic outcome following robotic radical trachelectomy for early stage cervical cancer. Methods All women with early stage cervical cancer planned for fertility-sparing robotic trachelectomy between December 2007 and April 2015 at two tertiary referral centers in Sweden were identified. Perioperative- and follow-up data was retrieved from prospective databases used for all robotic procedures at the respective institution and an additional review of computerized patient files was performed. Reproductive outcome evaluation was restricted to women with ≥ 12 months follow-up and an active wish to conceive. Oncological outcome was evaluated for all patients. Results Fifty-six women (3 stage IA1, 14 stage IA2 and 39 stage IB1) were included. The median age was 29 years (range 23-41). Median follow-up was 24 months (range 1-89). Seven trachelectomies were aborted in favor of a radical hysterectomy and/or chemoradiation due to nodal metastases or insufficient margins; two distant recurrences occurred in these women. A local recurrence was seen in two of the 49 women (4%) in whom the procedure was completed as planned. Seventeen of the 21 women (81%) in the reproductive follow-up group conceived - 16 naturally and one following IVF. Sixteen women (94%) delivered in the third trimester, 12 women (71%) in gestational week ≥ 36. One (6%) second trimester delivery occurred. Conclusion The high fertility rate, low rate of premature deliveries and an acceptable rate of recurrence support the feasibility of robotic fertility-sparing radical trachelectomy in women with early stage cervical cancer.
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| 10. |
- Nilsson Geppert, Barbara, et al.
(författare)
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A study on uterine lymphatic anatomy for standardization of pelvic sentinel lymph node detection in endometrial cancer
- 2017
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Ingår i: Gynecologic Oncology. - : Elsevier BV. - 0090-8258. ; 145:2, s. 256-261
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To describe the anatomy of uterine lymphatic drainage following cervical or fundal tracer injection to enable standardization of a pelvic sentinel lymph node (SLN) concept in endometrial cancer (EC). Methods: A prospective consecutive study of women with EC was conducted. A fluorescent dye (Indocyanine green) was injected into the cervix (n = 60) or the uterine fundus (n = 30). A systematic trans- and retroperitoneal mapping of uterine lymphatic drainage was performed. Positions of the pelvic SLNs, defined by afferent lymph vessels, and lymph node metastases were compared. Results: Two consistent lymphatic pathways with pelvic SLNs were identified irrespective of injection site; an upper paracervical pathway (UPP) with draining medial external and/or obturator lymph nodes and a lower paracervical pathway (LPP) with draining internal iliac and/or presacral lymph nodes. Bilateral display of at least one pelvic pathway following cervical and fundal injection occurred in 98% and 80% respectively (p = 0.005). Bilateral display of both pelvic pathways occurred in 30% and 20% respectively (p = 0.6) as the LPP was less often displayed. Nearly one third of the 19% node positive patients had metastases along the LPP. No false negative SLNs were identified. Conclusions: Based on uterine lymphatic anatomy a bilateral detection of at least one SLN in both the UPP and LPP should be aimed for. Absence of display of the LPP may warrant a full presacral lymphadenectomy. Although pelvic pathways and positions of SLNs are independent of the tracer injection site, cervical injection is preferable due to a higher technical success rate.
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