Expanding Opportunistic Bilateral Salpingectomy to Laparoscopic Cholecystectomy to Prevent Ovarian Cancer: A Feasibility and Safety Trial

The investigators will conduct a multi-center, open-label, non-inferiority clinical trial with two sites in British Columbia, Canada, and one site in Ontario, Canada. Recruitment will take place over 30 months from July 1, 2026, to January 31, 2029. Participants will be followed from preoperative assessment until 30 days following discharge from their surgery. The investigators will choose the nearest neighbor match by age at the same site as the intervention patient. The research coordinators (RC) will run each potential eligible control patient by the surgeon running that site to ensure that they would have been eligible for the trial, and their data will be obtained from their electronic medical record. All identifiable data will be removed and replaced with study IDs.

The RC at each site will have access to the electronic booking system at their site and screen eligible patients. They will approach patients and offer them the option to participate in a trial of opportunistic bilateral salpingectomy (OBS) during their laparoscopic cholecystectomy. If patients are interested, they will be provided with an information leaflet which includes a link to an online video, developed for patients, explaining OBS during general surgery. They will be provided with the electronic consent documents by email and offered a paper version should they prefer that option. Should there be any instances where an in-person consenting may not be possible or inconvenient, it will be done over the phone.

The investigators anticipate that 240 OBS patients will be recruited at the end of 30 months, which will ensure sufficient power for the main safety aims. The RC will attend the OR and will collect data on the fallopian tube removal. In the rare instances where the RC is not present, an OR nurse or another person in the OR will perform those duties. The RC will record how long it takes for the surgeon to remove both fallopian tubes. If the patient has had a prior tubal ligation, the surgeon will report that to the RC.

Start time: RC will begin timing fallopian tube removal when the camera and instruments are positioned away from the abdomen and into the pelvis, with or without insertion of additional port sites. The surgeon will signal when fallopian tube removal begins.

End time: The fallopian tube removal will be considered finished when both tubes are separated from the ovaries and uterus. The surgeon will signal when both tubes are separated from the ovaries and uterus, or when the attempt to remove both fallopian tubes was abandoned in cases where OBS was not feasible.