Safety of opportunistic salpingectomy for ovarian cancer prevention at laparoscopic sterilization

Abstract

Safety of opportunistic salpingectomy for ovarian cancer prevention at laparoscopic sterilization

Leonidas Magarakis

Department of Obstetrics and Gynecology, Institute of Clinical Sciences Sahlgrenska Academy, University of Gothenburg Gothenburg, Sweden

Since the first evidence linking ovarian cancer tumorigenesis to the Fallopian tubes emerged, the idea of removing the Fallopian tubes during benign gynecologic surgery as a preventive strategy has gained attention. This approach is appealing due to its relative simplicity and general belief of minimal additional risk. Retrospective observational studies have demonstrated that salpingectomy is associated with greater ovarian cancer risk reduction compared with tubal occlusion procedures. Consequently, opportunistic salpingectomy has increasingly been performed in place of tubal occlusion during sterilization procedures, despite limited evidence regarding its surgical and endocrine safety.

Paper I: This thesis first aimed to systematically review the literature and evaluate the evidence on salpingectomy for sterilization. In this review no studies examined ovarian cancer risk. Regarding ovarian function, one randomized controlled trial during Cesarean section found no difference in anti-Müllerian hormone levels after surgery, while two cohort studies using surrogate measures similarly reported no ovarian function changes. Complication rates showed no significant differences between procedures, though assessment and reporting methods varied. Laparoscopic tubal occlusion proved slightly faster than salpingectomy. The certainty of evidence for all these outcomes was rated as low or very low, highlighting substantial remaining knowledge gaps in this field.

Paper II: Given the low certainty evidence, a national, register-based randomized trial with non-inferiority design, the SALSTER trial (SALpingectomy for STERilization), was designed and conducted. The Swedish National Quality Register for Gynecological Surgery (GynOp), augmented with additional modules, served as the digital platform for eligibility screening, study information dissemination, informed consent collection, randomization, intraoperative data registration, and postoperative follow-up. SALSTER’s aim was to assess the safety of salpingectomy for laparoscopic sterilization regarding complications and ovarian function. Age at menopause remains the most reliable indicator of ovarian function and is a long-term primary outcome in SALSTER. To provide early insight into potential effects of salpingectomy on ovarian function, anti-Müllerian hormone (AMH) levels were measured preoperatively and one year postoperatively in a subgroup of the cohort. The difference in change in AMH levels between the groups was compared to evaluate the impact of salpingectomy on ovarian function.

Paper III: The trial randomized 1,066 participants. Based on imputed data analysis in the per-protocol population, minor and major complications, within eight weeks occurred in 8.1% (38.5/473) of patients undergoing salpingectomy compared with 6.2% (31.0/499) of those receiving tubal occlusion, yielding a risk difference of 1.9 percentage points (95% CI −1.4 to 5.3). The primary outcome demonstrated that salpingectomy did not increase complication rates beyond the predefined non-inferiority margin, confirming its safety profile relative to tubal occlusion. Salpingectomy required a longer operative time compared with tubal occlusion (44 vs. 29 minutes), with a mean difference of 16 minutes (95% CI 14 to 18).

Paper IV: A nested sub-study enrolled 147 participants, of whom 135 (91.8%) met per-protocol criteria. Follow-up blood samples were collected from 75 participants (55.5% of eligible cases). In the complete case analysis, the adjusted mean difference in AMH change was 0.04 μg/L (95% CI −0.63 to 0.71). While both groups exhibited comparable AMH decline, the study could neither establish nor refute non-inferiority.

This study addresses a critical gap by providing high-quality evidence on the perioperative safety of laparoscopic opportunistic salpingectomy for sterilization. The follow up of SALSTER will generate essential data on the procedure’s endocrine safety profile, evaluating whether salpingectomy is non-inferior to tubal occlusion in preserving ovarian hormone function. These findings will support clinicians in shared decision-making, while future research investigates salpingectomy’s potential role in ovarian cancer prevention, a disease typically diagnosed at advanced stages with poor survival outcomes.