Salpingectomy versus tubal occlusion in laparoscopic sterilisation (SALSTER): a national register-based randomised non-inferiority trial.

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.