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Background 

Opportunistic salpingectomy at the time of hysterectomy, i.e., removing presumed healthy fallopian tubes when removing the uterus, is suggested to reduce the risk of ovarian cancer. However, the impact of opportunistic salpingectomy on complications and ovarian function is insufficiently studied. Furthermore, the perspectives of women with no increased risk of ovarian cancer facing the choice to undergo opportunistic salpingectomy at hysterectomy have not been previously explored. There is consensus that surgical complications are important to register, both for quality control and research. Nevertheless, internationally there is no agreement on when, how, and even what to register, which reduces the comparability. This thesis aimed to compare complication rates and menopausal symptoms after opportunistic salpingectomy, as well as to explore women’s views on hysterectomy and salpingectomy before surgery. Furthermore, it aimed to validate complication registration after uterine and adnexal surgery in the Swedish National Quality Register of Gynecological Surgery (GynOp).

Methods

A retrospective cohort study with data from GynOp (Paper I), explored the uptake of opportunistic salpingectomy in Sweden 1998-2016. Hysterectomy with bilateral salpingectomy vs hysterectomy only, performed 2013-2016, was compared regarding complications and menopausal symptoms one year after surgery. Paper II is a qualitative study, with focus group discussions including women waiting for hysterectomy in different parts of Sweden. The participants’ experiences and perceptions of health, healthcare, and potential outcomes of hysterectomy with or without salpingectomy were explored. For Paper III, a cross-sectional study based on a survey sent to Swedish gynecologists was conducted. Fictional cases describing various postoperative courses were used to explore interrater reliability in assessing complications according to the methods in GynOp. Finally, a cohort study including surgeries of the uterus and/or adnexa with benign indications 2017-2020 was conducted. Complications registered in GynOp, the National Patient Register, Prescribed Drug Register, and Cause of Death Register were compared (Paper IV).

Results

The uptake of bilateral salpingectomy at the time of hysterectomy increased from 1.9% in 2012 to 37.8% in 2016. Comparing hysterectomy with bilateral salpingectomy vs hysterectomy only, salpingectomy was associated with an increased risk of menopausal symptoms one year after surgery (adjusted relative risk (aRR) 1.35, 95% confidence interval (CI) 1.07-1.71)). A slight increase in mean length of hospital stay (0.1 day, 95% CI 0.01-0.17) was seen, as well as an increased risk of minor complications in unadjusted analysis (relative risk (RR) 1.36, 95% CI 1.05-1.77). The latter was, however, not significant after adjusting for potential confounders (aRR 1.29, 95% CI 0.92-1.82) (Paper I). Women waiting for hysterectomy expressed that healthcare personnel held differing perspectives from the women, both regarding the surgery and the health problems being the cause of surgery. They also perceived a dependency on the advice and opinion of the physician for the choice of surgical procedure and possibly having opportunistic salpingectomy (Paper II). Swedish gynecologists demonstrated high interrater reliability in assessing whether a complication had occurred (agreement >80% in 85% of cases (17/20)), and in using the Clavien-Dindo classification, (agreement >90% in 80% of cases (16/20)) in our survey. Cases with lower agreement rates were bordering between minor complications and normal postoperative course (Paper III). From 2017 to 2020, 32,537 surgeries of the uterus and/or adnexa were registered in GynOp (Paper IV). Higher rates of complications from discharge to three months were found in GynOp compared with the Patient Register (13.7% vs 6.9%). The coverage of all complications was 79.1% in GynOp and 46.1% in the Patient Register when linking the two registers. Of the included individuals, 12.7% had a prescription of antibiotics ≤30 days after surgery, indicating a postoperative infection.

Conclusions

This thesis suggests that bilateral salpingectomy at the time of hysterectomy affects ovarian function and might increase the risk of minor complications, concerns which must be properly addressed in the consultation before surgery as well as in future research. Research on surgical interventions require reliable tools for evaluating complications. In finding a higher rate of complications captured in GynOp compared with the health registers, and a high interrater reliability among Swedish gynecologists, the registration of complications in GynOp are validated. However, continued work is required with definitions of what is normal in recovery after any specific surgery, for reliable capture of complications and to provide adequate information before surgery.  Shared decision-making based on high quality scientific evidence of risks and benefits is important in all interventions, especially in prophylactic surgery, e.g., opportunistic salpingectomy.

Introduction: The 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 methods: A national register-based study using prospectively collected data was conducted, including women who had surgery of 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, 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 cause of death if occurring within three months of surgery and prescription of antibiotics ≤30 days. Comparisons between the registries were descriptive. 

Results: During the study period 32 537 surgeries were performed, whereof 26 214 (80.6%) 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 three months after surgery. In comparison, according to the Patient Register 2254 women (6.9%) had postoperative complications within three months of discharge (difference of 6.8 percentage points (95% confidence interval 7.2, 6.2)). 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. 

Conclusion: A 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. 

Background: Diagnosis of an adnexal mass might be a sign of ovarian cancer, with an overall poor prognosis. This study aimed to explore women’s experiences and perceptions of facing ovarian surgery due to an adnexal mass, and expectations on life after surgery.

Methods: Individual in-depth interviews with 15 women facing ovarian surgery due to an adnexal mass. Interviews were analysed using qualitative content analysis.

Results: An overarching theme, From symptoms to surgery–a pathway through uncertainty and hope, was identified. The theme was made up of three categories; I. The road to diagnosis, II. Striving for information and guidance, and III. Balancing emotions of hope and fear. The period between discovering the adnexal mass and surgery was often described as chaotic and difficult to manage. However, the diagnostic procedures were mostly described as timely and efficient, and participants felt safe and cared for. Person-centred care was considered crucial when being in this vulnerable situation, and the nurse navigator was described as a key person to approach for any queries. While participants expressed overall satisfaction with the information provided by health professionals, some reported a lack of information regarding the surgery’s potential impact on hormonal production and sexuality. Restrictions during the COVID-19 pandemic forced participants to attend healthcare visits alone, and some wished that health professionals had taken more responsibility for informing their relatives. Many participants focused on the positive aspects of the information gained about the adnexal mass, and that the entire situation gave perspective of what was important in life.

Conclusions: Waiting for surgery on a possibly malignant adnexal mass can be very stressful, however person-centred care and the guidance of a nurse navigator can make the process more manageable. To improve women’s experience, health professionals may involve relatives more often and make sure to inform of potential hormonal loss and sexuality after ovarian surgery.

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 https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-3083-8. 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.

Trial registration: ClinicalTrials.gov, NCT03045965. Registered 8 February 2017.

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.

Background: Hysterectomy is a common procedure worldwide and removing healthy fallopian tubes at the time of hysterectomy (opportunistic salpingectomy) to possibly prevent ovarian cancer is increasing in frequency, but still controversial. The experiences and perceptions of women, eligible for the procedure, have not been previously investigated. This study aims to, among women waiting to undergo hysterectomy, explore i) experiences and perceptions of self and healthcare in relation to their elective surgery, ii) perceptions of risks and benefits of hysterectomy, including opportunistic salpingectomy.

Methods: A qualitative study, with focus group discussions including women < 55 years, planned for hysterectomy with ovarian preservation, was performed. Participants were recruited through purposive sampling from six gynecological departments in different parts of Sweden, including both country and university hospitals. Focus group discussions were conducted using a semi-structured interview guide, digitally recorded, transcribed verbatim and analysed by qualitative manifest and latent content analysis.

Results: Twenty-one Swedish-speaking women participated. They were 40-53 years of age, reported varying educational levels, countries of birth and indications for hysterectomy. Analysis rendered a theme "Bridging different realities" over four categories: "Being a woman today", "Experiencing and managing body failure", "Navigating the healthcare system" and "Processing continuously until surgery", including 17 subcategories. The participants displayed varying attitudes towards the significance of their uterus in being a woman. A vague understanding of their body was described, leading to fear related to the reasons for surgery as well as surgery itself. Participants described difficulties understanding and recalling information but also stated that insufficient information was provided. Perceptions of the risks and benefits of opportunistic salpingectomy varied. Involvement in decisions regarding the hysterectomy and potential opportunistic salpingectomy was perceived to be dependent on the counselling gynecologist.

Conclusions: The theme Bridging different realities captures the complexity of women deciding on removal of their uterus, and possibly fallopian tubes. It also describes the women's interactions with healthcare and perceived difference between the health professionals and the women's perception of the situation, as viewed by the women. Bridging the different realities faced by patients is required to enable shared decision-making, through sufficient support from healthcare.

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.