| 1. |
- Collins, Elin, et al.
(författare)
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Complications after benign gynecologic surgery-How are they captured in register-based research? A national register study in Sweden
- 2024
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Ingår i: ACTA OBSTETRICIA ET GYNECOLOGICA SCANDINAVICA. - : John Wiley & Sons. - 0001-6349 .- 1600-0412.
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionThe evidence on complication rates after gynecological surgery is based on multiple types of studies, and the level of evidence is generally low. We aimed to validate the registration of complications in the Swedish National Quality Register of Gynecological Surgery (GynOp), by cross-linkage to multiple national registers.Material and MethodsA national register-based study using prospectively collected data was conducted, including women who had surgery on the uterus or adnexa for benign indications from January 1, 2017, to December 31, 2020. In Sweden, complications after gynecological surgery are registered in GynOp, and if the complication has rendered any interaction with healthcare, it is also in national health registers. The GynOp register, the National Patient Register, the Prescribed Drugs Register, and the Cause of Death Register were cross-linked. Complications in GynOp and complications according to ICD10 were analyzed, as well as the cause of death if occurring within 3 months of surgery and prescription of antibiotics <= 30 days. Comparisons between the registries were descriptive.ResultsDuring the study period 32 537 surgeries were performed, of which 26 214 (80.6%) were minimally invasive. Complications were reported in GynOp for 569 women (1.7%) at surgery, 1045 (3.2%) while admitted, and 3868 (13.7%) from discharge to 3 months after surgery. In comparison, according to the Patient Register, 2254 women (6.9%) had postoperative complications within 3 months of discharge (difference of 6.8 percentage points [95% confidence interval 6.2-7.2]). Furthermore, 4117 individuals (12.7%) had a prescription of antibiotics <= 30 days which could indicate a postoperative infection. The rates of hemorrhage, wound dehiscence, and thrombosis were comparable between GynOp and the Patient Register while diagnoses not leading to contact with specialized care had higher rates in the quality register. The coverage of complications was 79.1% in GynOp and 46.1% in the Patient Register, using the total number of complications from both registers as the denominator.ConclusionsA higher frequency of complications is captured in GynOp than in the National Patient Register. Patient-reported outcomes assessed by a physician are beneficial in identifying complications indicating the importance of structured pre-defined follow-up over a set period. GynOp, a national quality register for gynecological surgery captures more complications than the national health registers. A structured follow-up, including patient reported and physician assessed complications after surgery, is beneficial in describing the full spectrum of postoperative complications.image
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| 2. |
- Collins, Elin, et al.
(författare)
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Menopausal symptoms and surgical complications after opportunistic bilateral salpingectomy, a register-based cohort study
- 2019
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Ingår i: Am J Obstet Gynecol. - : Elsevier BV. - 0002-9378 .- 1097-6868. ; 220:1
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: In recent years, the fallopian tubes have been found to play a critical role in the pathogenesis of ovarian cancer. Therefore, bilateral salpingectomy at the time of hysterectomy has been proposed as a preventive procedure, but with scarce scientific evidence to support the efficiency and safety. OBJECTIVE: Our primary objective was to evaluate the risk of surgical complications and menopausal symptoms when performing bilateral salpingectomy in addition to benign hysterectomy. Furthermore, we sought to compare time in surgery, perioperative blood loss/blood transfusion, duration of hospital stay, days to normal activities of daily living, and days out of work for hysterectomy with bilateral salpingectomy compared with hysterectomy only. A secondary objective was to study the uptake of opportunistic salpingectomy in Sweden. STUDY DESIGN: This was a retrospective observational cohort study based on data from the National Quality Register of Gynecological Surgery in Sweden. Women <55 years of age who had a hysterectomy for benign indications with or without bilateral salpingectomy in 1998 through 2016 were included. Possible confounding was adjusted for in multivariable regression models. RESULTS: During the study period, 23,369 women had a hysterectomy for benign indications. The frequency of bilateral salpingectomy at the time of hysterectomy increased mainly from 2013, which is why the period 2013 through mid-2016 was selected for further analysis (n = 6892). There was a low frequency of vaginal hysterectomy with bilateral salpingectomy performed in this period, which is why only abdominal and laparoscopic surgeries were selected for comparative analysis (n = 4906). This study indicates an increased risk of menopausal symptoms (adjusted relative risk, 1.33; 95% confidence interval, 1.04-1.69) 1 year after hysterectomy with bilateral salpingectomy compared with hysterectomy only. Hospital stay was 0.1 days longer in women having salpingectomy (P = .01), and bleeding was slightly reduced in the salpingectomy group (-20 mL, P = .04). Other outcome measures were not significantly associated with salpingectomy, albeit a tendency toward higher risk of minor complications was seen (adjusted relative risk, 1.30; 95% confidence interval, 0.93-1.83). CONCLUSION: Bilateral salpingectomy at the time of hysterectomy was associated with an increased risk of menopausal symptoms 1 year after surgery. Randomized clinical trials reducing the risk of residual and unmeasured confounding and longer follow-up are needed to correctly inform women on the risks and benefits of opportunistic salpingectomy.
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| 3. |
- Collins, Elin, et al.
(författare)
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Physicians' assessment of complications after gynecological surgery in Sweden : The GYNCOM survey
- 2023
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : John Wiley & Sons. - 0001-6349 .- 1600-0412. ; 102:11, s. 1479-1487
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Complications after gynecological surgery in Sweden are registered in the well-established Swedish National Quality Register of Gynecological Surgery, GynOp. The aim of this study was to analyze interrater reliability in assessing complications according to the methods in GynOp, and to explore physicians' perceptions of registering complications.Material and methods: A digital survey was sent to gynecologists and residents in gynecology in Sweden. Participating clinics were recruited through the Swedish network for national clinical studies in Obstetrics and Gynecology, SNAKS. Twenty fictional cases, intended to represent normal postoperative course, failure to cure, and varying degrees of complications, were developed by the research group. The clinical scenarios included abdominal and laparoscopic surgery of the uterus and adnexa, vaginal hysterectomies, as well as hysteroscopy. The respondents graded each case on the presence of a complication (yes/no). Type of complication, severity, and what action the complication required according to Clavien-Dindo was registered if a complication was acknowledged, according to the method in GynOp. Interrater reliability and the opinions of the respondents were presented descriptively. More than 80% of respondents making the same assessment was considered as agreement.Results: The response rate was 41%, with 104 responding physicians from 16 gynecological clinics. Type and severity of complication was considered relevant to register by 88% and 89% of respondents, respectively. Agreement on whether the case described a complication was >80% in 85% (17/20) of cases and agreement using the Clavien-Dindo classification was >90% in 80% (16/20) of cases. There was high agreement in assessments of classically severe complications, such as pulmonary embolism and ureteral damage, in both presence of complication and severity, as well as Clavien-Dindo (>90% for all methods). Cases with agreement <80% on whether the case described a complication were bordering between normal postoperative course and minor complication.Conclusions: This study provides validation for the methods used to register complications after gynecological surgery according to the GynOp register, including the use of Clavien-Dindo in gynecology. However, the results indicate a need to define what should be considered symptoms inherent to each type of surgery.
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| 4. |
- Idahl, Annika, 1965-, et al.
(författare)
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HOPPSA update: changes in the study protocol of Hysterectomy and OPPortunistic SAlpingectomy, a registry-based randomized controlled trial
- 2023
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Ingår i: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 24:1
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Tidskriftsartikel (refereegranskat)abstract
- Background The HOPPSA trial is a multi-center national registry-based randomized controlled trial to test the safety and effectiveness of performing opportunistic salpingectomy at hysterectomy to reduce the risk of epithelial ovarian cancer (EOC). The study protocol was first published in January 2019 and is available at . Here, we report amendments made to the study protocol since commencement of the trial.Changes in methods and analysis The primary outcomes analyses have been changed. (1) Complications will be analyzed using binomial generalized estimating equation (GEE) with log link function, while the unadjusted analyses according to Miettinen and Nurminen will be performed as a sensitivity analysis. (2) Absolute change in Menopause Rating Scale (MRS) will primarily be analyzed using a mixed effects model, adjusted for baseline MRS and center as a random effect. (3) Time to EOC will be analyzed using the mixed effects Cox regression model with center as random effect, while the unadjusted log-rank test will be performed as a sensitivity analysis.The primary outcome Complications will be based solely on the specific assessment in the GynOp quality registry. The Clavien-Dindo classification will be evaluated as a secondary outcome.Furthermore, MRS is also measured three years postoperatively to better pinpoint the onset of menopausal symptoms.Discussion The changes to the protocol mainly concern the analyses of data. No changes to recruitment, randomization, intervention, or follow-up of primary outcomes have been made. An interim analysis during 2021 concluded that the study should continue until the target sample size is reached.
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| 5. |
- Idahl, Annika, 1965-, et al.
(författare)
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Hysterectomy and opportunistic salpingectomy (HOPPSA): study protocol for a register-based randomized controlled trial
- 2019
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Ingår i: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 20
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundThere is a great need for a prospective randomized trial to evaluate the risks and benefits of opportunistic salpingectomy. Recently, genetic and morphologic studies have indicated that epithelial ovarian cancer predominantly develops in the Fallopian tubes. Consequently, there is reason to believe that salpingectomy would reduce the risk of ovarian cancer. Studies on reducing the risk of ovarian cancer have compared indicated salpingectomy with no salpingectomy, while studies on surgical safety as well as ovarian function after opportunistic salpingectomy have been small with a short follow-up. No study has reported menopausal symptoms.Methods/designIn this national register-based randomized controlled trial, women <55years old, planned for a hysterectomy for a benign cause, will be randomized to concomitant salpingectomy or no salpingectomy. The follow-up will be conducted according to already established routines within the register using on-line questionnaires. Primary outcomes have been defined for three different time points: short-term complications up to 8 weeks postoperatively (n=2800), intermediate-term changes in menopausal symptoms measured by the Menopause Rating Scale at baseline and after 1 year (n=1670), and long-term epithelial ovarian cancer assessed through national registers after 30years (n=5052) (or n=7001 for high-grade serous cancer). In a sub-study of 75 women, ovarian function will be evaluated through change in anti-Mullerian hormone measured before surgery and after 1 year.DiscussionHysterectomy for a benign cause is a common surgical procedure and several national societies recommend salpingectomy while performing a benign hysterectomy, despite a lack of scientific evidence for the safety of the procedure. Sweden has unique conditions for clinical trials because of its national quality registers and health registers with excellent quality and near complete coverage. If no additional risks are associated with concomitant salpingectomy, it can be recommended at the time of benign hysterectomy to reduce the risk of epithelial ovarian cancer. If not, the risks and benefits must be balanced. The results of this study will be important for informing women undergoing a benign hysterectomy.Trial registrationClinicalTrials.gov, NCT03045965. Registered on 8 February 2017.
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| 6. |
- Magarakis, Leonidas, et al.
(författare)
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Efficacy and safety of sterilisation procedures to reduce the risk of epithelial ovarian cancer: a systematic review comparing salpingectomy with tubal ligation
- 2022
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Ingår i: European Journal of Contraception and Reproductive Health Care. - : Informa UK Limited. - 1362-5187 .- 1473-0782. ; 27:3, s. 230-239
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Forskningsöversikt (refereegranskat)abstract
- Purpose: The objective of this systematic review is to evaluate current literature comparing salpingectomy for sterilisation with tubal ligation, regarding the effectiveness and safety, and assess the certainty of evidence. Materials and methods: PubMed, Cochrane, and Embase databases were searched. Randomised (RCT) and observational studies were included. Articles were quality assessed and data extracted by two independent authors. Certainty of evidence was assessed using GRADE. Results: Of 2020 articles, 17 were included. No study investigated the risk of EOC. No difference in anti-Müllerian hormone was reported in one RCT at caesarean section (CS). Two cohort studies evaluated ovarian function with surrogate measures and found no difference at caesarean section. Complications did not differ but were inconsistently reported. Laparoscopic tubal ligation was 7 min faster (95% CI 3.8–10.5). Operative time at caesarean section was dependent on the use of surgical devices. Certainty of evidence was low or very low for all estimates, indicating knowledge gaps. Reliable safety data on salpingectomy for sterilisation is lacking, and there is no effectiveness data. Presently, women cannot be properly counselled regarding salpingectomy for sterilisation.
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| 7. |
- Magarakis, Leonidas, et al.
(författare)
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SALpingectomy for STERilisation (SALSTER): study protocol for a Swedish multicentre register-based randomised controlled trial.
- 2023
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Ingår i: BMJ open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 13:9
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Tidskriftsartikel (refereegranskat)abstract
- Salpingectomy is currently suggested as an alternative to tubal ligation for sterilisation. Precursor lesions of ovarian carcinoma can be found in the fallopian tubes; thus, salpingectomy could possibly reduce the incidence. Most of the existing trials on safety are small, on caesarean section and report on surrogate ovarian function measures. Randomised trials in laparoscopy are lacking. Well-designed trials are needed to evaluate safety of laparoscopic opportunistic salpingectomy.In SALSTER, a national register-based randomised controlled non-inferiority trial, 968women <50 years, wishing laparoscopic sterilisation will be randomised to either salpingectomy or tubal ligation. The Swedish National Quality Register of Gynecological Surgery (GynOp) will be used for inclusion, randomisation and follow-up. Primary outcomes are any complication up to 8weeks postoperatively, and age at menopause. Both outcomes are measured with questionnaires, complications are also assessed by a gynaecologist. In a nested trial, ovarian function will be evaluated comparing the mean difference of anti-Müllerian hormone (AMH), assessed preoperatively and 1year after surgery.Performing salpingectomy for sterilisation has become increasingly common, despite the unclear risk-benefit balance. SALSTER studies the safety of salpingectomy compared with tubal ligation. Regardless of the result, SALSTER will provide gynaecologists with high quality evidence to inform women to decide on salpingectomy or not. The central ethical review board of Gothenburg, Sweden (Dnr. 316-18) approved the trial in 2018. Results will be presented at scientific congresses and published in peer-reviewed scientific journals. The results will be communicated through professional organisations and research networks.NCT03860805.
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| 8. |
- Merritt, Melissa A., et al.
(författare)
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Dietary fat intake and risk of epithelial ovarian cancer in the European Prospective Investigation into Cancer and Nutrition
- 2014
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Ingår i: Cancer Epidemiology. - : Elsevier BV. - 1877-7821 .- 1877-783X. ; 38:5, s. 528-537
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Tidskriftsartikel (refereegranskat)abstract
- There are inconsistent and limited data available to assess the relationship between fat intake and risk of epithelial ovarian cancer (EOC). We examined the consumption of total fat, fat sources and fat subtypes in relation to risk of EOC and its major histologic subtypes in the European Prospective Investigation into Cancer and Nutrition which includes incident invasive (n = 1095) and borderline (n = 96) EOC. Cox proportional hazards regression was used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). In multivariate models, we observed no association with consumption of total fat, animal or plant fat, saturated fat, cholesterol, monounsaturated fat, or fatty fish and risk of invasive EOC. There was, however, an increased risk of invasive EOC in the highest category of intake (Quartile 4 vs. Quartile 1) of polyunsaturated fat (HR = 1.22, 95% CI = 1.02-1.48, P-trend = 0.02). We did not observe heterogeneity in the risk associations in comparisons of serous and endometrioid histologic subtypes. This study does not support an etiological role for total fat intake in relation to EOC risk; however, based on observations of a positive association between intake of polyunsaturated fat and invasive EOC risk in the current and previous studies, this fat subtype warrants further investigation to determine its potential role in EOC development.
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| 9. |
- Roura, Esther, et al.
(författare)
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The Influence of Hormonal Factors on the Risk of Developing Cervical Cancer and Pre-Cancer: Results from the EPIC Cohort
- 2016
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Ingår i: PLoS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 11:1
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Tidskriftsartikel (refereegranskat)abstract
- In addition to HPV, high parity and hormonal contraceptives have been associated with cervical cancer (CC). However, most of the evidence comes from retrospective case-control studies. The aim of this study is to prospectively evaluate associations between hormonal factors and risk of developing cervical intraepithelial neoplasia grade 3 (CIN3)/carcinoma in situ (CIS) and invasive cervical cancer (ICC).
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| 10. |
- Strandell, Annika, et al.
(författare)
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Salpingectomy versus tubal occlusion in laparoscopic sterilisation (SALSTER) : a national register-based randomised non-inferiority trial
- 2024
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Ingår i: The Lancet Regional Health. - : Elsevier. - 2666-7762.
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Tidskriftsartikel (refereegranskat)abstract
- Background: Opportunistic salpingectomy to reduce ovarian cancer incidence has become increasingly common despite the lack of randomised trials investigating its safety. In SALSTER, we tested whether salpingectomy for laparoscopic sterilisation is non-inferior to tubal occlusion regarding complications up to eight weeks postoperatively.Methods: SALSTER is a register-based randomised non-inferiority trial in which 41 gynaecological departments in Sweden participated. After being reported to The Swedish National Quality Register of Gynaecological Surgery (GynOp) for laparoscopic sterilisation, women aged <50 years received study information and could consent to participation online. If eligible, randomisation was performed by the examining/operating gynaecologist before surgery, with stratification for centre, and allocation 1:1 to salpingectomy or tubal occlusion. Blinding was attempted for patients but was impossible for surgeons. The first primary outcome, any complication up to eight weeks postoperatively, was routinely reported in GynOp through physician assessment of patient questionnaires, medical records and personal contact. Complications up to eight weeks postoperatively, a primary safety outcome, were analysed in the per-protocol population. The non-inferiority margin for the difference in the absolute risk of complications was defined as ten percentage points. Missing data were handled using multiple imputation. SALSTER was registered at ClinicalTrials.gov (NCT03860805).Findings: Between April 4, 2019, and March 31, 2023, 539 women were randomised to salpingectomy and 527 to tubal occlusion. In the salpingectomy and tubal occlusion arms, 40 and 18 women discontinued their participation in the trial and another 26 and 10 did not receive the allocated surgery, respectively. Calculated on imputed data, any complication up to eight weeks postoperatively occurred in 8.1% (38.5/473) of patients after salpingectomy and in 6.2% (31.0/499) of patients after tubal occlusion. The risk difference was 1.9 percentage points (95% confidence interval −1.4 to 5.3).Interpretation: Laparoscopic salpingectomy is non-inferior to tubal occlusion regarding complication rates up to eight weeks postoperatively. Funding: This research was funded by the Swedish Cancer Society, the Lena Wäppling foundation, the Swedish state under the ALF-agreement, Umeå University, County of Värmland, and Gothenburg Society of Medicine.
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