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SALpingectomy for STERilisation (SALSTER): study protocol for a Swedish multicentre register-based randomised
Leonidas Magarakis1, Annika Idahl2, Karin Sundfeldt3,4
1Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden leonidas.magarakis@gu.se.
Introduction:
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.
Methods And Analysis:
In 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 are any complication up to 8 weeks 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 1 year after surgery.
Ethics And Dissemination:
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.
Trial Registration Number:
NCT03860805.
Insights
Salpingectomy is a safe alternative to tubal ligation for sterilization, potentially reducing ovarian cancer risk. The SALSTER trial provides evidence for informed patient decisions on this laparoscopic procedure.
Area of Science:
- Gynecology
- Surgical Oncology
- Reproductive Health
Background:
- Salpingectomy is increasingly used for sterilization, but its safety and benefits compared to tubal ligation are not fully established.
- Ovarian cancer precursor lesions in fallopian tubes suggest salpingectomy may reduce incidence.
- Existing safety data are limited, with a lack of randomized laparoscopic trials.
Purpose of the Study:
- To evaluate the safety and efficacy of laparoscopic opportunistic salpingectomy compared to tubal ligation for sterilization.
- To provide high-quality evidence for clinicians and patients regarding the risk-benefit balance of salpingectomy.
Main Methods:
- The SALSTER trial is a national, register-based, randomized controlled non-inferiority trial.
- 968 women under 50 desiring laparoscopic sterilization were randomized to salpingectomy or tubal ligation.
- Primary outcomes include postoperative complications and age at menopause; ovarian function is assessed via anti-Müllerian hormone levels.
Main Results:
- The SALSTER trial is ongoing and results are pending.
- This study aims to provide definitive data on the safety of laparoscopic salpingectomy.
Conclusions:
- The SALSTER trial will offer crucial evidence to guide clinical practice and patient choice regarding salpingectomy for sterilization.
- Results will inform the gynecological community on the comparative safety of salpingectomy versus tubal ligation.
