Menopausal Impact of Opportunistic Salpingectomy for Ovarian Cancer Prevention

NCT07423143NOT_YET_RECRUITINGNAINTERVENTIONAL

Summary

The goal of this clinical trial is to find out whether removing the fallopian tubes at the time of hysterectomy leads to an earlier menopause. The study includes women under 55 years of age who previously underwent hysterectomy as participants in the HOPPSA trial, where they were randomly assigned to either removal of the fallopian tubes or no removal. The main question is: • Does removing the fallopian tubes at the time of hysterectomy lead to an earlier menopause? Researchers will compare women who had their fallopian tubes removed during hysterectomy with women who had hysterectomy alone to see whether menopause occurs earlier after tube removal. Age at menopause will be estimated by measuring follicle-stimulating hormone (FSH) in small blood samples collected on a paper card. Participants will: * Collect 4-5 drops of blood using a finger prick * Place the drops on a paper card and mail it to the researchers * Complete an online questionnaire These steps will be done twice, one year apart.

Key Facts

Lead Sponsor

Umeå University

Enrollment

2100

Start Date

2026-03-01

Completion Date

2029-02-01

Study Type

INTERVENTIONAL

Official Title

Menopausal Impact of Opportunistic Salpingectomy for Ovarian Cancer Prevention

Interventions

Opportunistic salpingectomy

Conditions

MenopauseOpportunistic Salpingectomy

Eligibility

Age Range

20 Years – 65 Years

Sex

FEMALE

Inclusion Criteria:

* Having had hysterectomy for a benign indication
* Less than 55 years at surgery
* Was included in the ITT population of the HOPPSA register-based randomised controlled trial (R-RCT) of opportunistic salpingectomy
* Informed consent

Exclusion Criteria:

* Ongoing systemic hormonal treatment using sex steroids
* Bilateral oophorectomy
* Cancer treatment affecting ovarian function
* Other treatments with major effects on ovarian function

Outcome Measures

Primary Outcomes

Age at menopause

Evaluated using serum follicle-stimulating hormone (FSH) levels analysed in self-sampled dried blood spots. Continuous outcome measured in years. Samples collected twice one year apart.

Time frame: 1 year

Secondary Outcomes

Cardiovascular disease - CVD

Dichotomous outcome. Diagnosis will be classified according to ICD-10. Data from national health registers will be retrieved. The outcome will be further described according to types of cardiovascular disease, i.e. coronary heart disease and stroke, as well as age at CVD.

Time frame: 10-30 years after enrolment.

Mortality

Dichotomous outcome, the diagnosis is classified according to ICD-10. Data retrieved from the national Cause of Death Register. Mortality will be further described as all-cause mortality, and mortality due to cardio-vascular disease.

Time frame: 10-30 years after enrolment.

Locations

Umeå University, Umeå, Sweden

Linked Papers

2023-09-04

SALpingectomy for STERilisation (SALSTER): study protocol for a Swedish multicentre register-based randomised controlled trial

IntroductionSalpingectomy 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.Methods and analysisIn SALSTER, a national register-based randomised controlled non-inferiority trial, 968 women <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 areany complicationup to 8 weeks postoperatively, andage 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 1 year after surgery.Ethics and disseminationPerforming 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.Trial registration numberNCT03860805.

2023-03-24

HOPPSA update: changes in the study protocol of Hysterectomy and OPPortunistic SAlpingectomy, a registry-based randomized controlled trial

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 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.

Opportunistic Salpingectomy for Prevention of Tubo-Ovarian Carcinoma

Importance The fallopian tube epithelium has been demonstrated to be an important source of tubo-ovarian carcinoma. Therefore, removal of the fallopian tubes during unrelated pelvic or abdominal surgery (opportunistic salpingectomy) can potentially lower future ovarian cancer risk. Objectives To assess current evidence on the efficacy, risks, and long-term outcomes of opportunistic salpingectomy and to develop consensus statements for the European Society of Gynaecological Oncology. Evidence Review An international working group of 14 individuals including a patient representative was formed to develop consensus statements on opportunistic salpingectomy. The MEDLINE database was used to conduct a literature review of English-language studies from January 1, 2000, through March 1, 2025, evaluating opportunistic salpingectomy for reduction of tubo-ovarian carcinoma, complication rates, additional surgical time, and impact on ovarian function. Statements were subsequently drafted collaboratively based on the review of the literature and adapted in an iterative process in conference call meetings with opportunity for anonymous and nonanonymous feedback. The anonymous voting was binary (agree/disagree) for each potential statement. Final statements reached consensus with more than 75% agreement. Findings In the literature review, 230 studies were identified, of which 129 were deemed relevant to consensus statement development. Consensus was achieved on 18 statements, with grades of recommendation ranging from B to D and levels of evidence from II to V. Opportunistic salpingectomy is significantly associated with a lower risk of subsequent tubo-ovarian carcinoma, with no adverse short-term impact on ovarian function. The procedure appears safe across surgical approaches, with little additional operative time. Existing evidence does not indicate harm to ovarian function or premature menopause, although long-term evidence is not available. Salpingectomy is feasible during both gynecological and nongynecological procedures and should be considered in women undergoing gynecological surgery and, where possible, in women undergoing selected nongynecological pelvic or abdominal surgeries. Conclusions and Relevance Existing evidence demonstrates that opportunistic salpingectomy is significantly associated with a lower risk of developing tubo-ovarian carcinoma. Clinicians should include this prevention intervention in preoperative counseling of eligible women.

Linked Investigators

Annika Idahl

Leonidas Magarakis

Menopausal Impact of Opportunistic Salpingectomy for Ovarian Cancer Prevention