Preventing Ovarian Cancer Through Opportunistic Salpingectomy at the Time of Laparoscopic Cholecystectomy

NCT07625137 | Not Yet Recruiting

• 1 other identifier: H26-00688
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

Brief Summary

This study aims to evaluate the feasibility, safety, and cost-effectiveness of opportunistic salpingectomy (OS-the removal of the fallopian tubes) at the time of laparoscopic cholecystectomy (the removal of the gallbladder) to prevent ovarian cancer. Ovarian cancer is the fifth leading cause of cancer-related mortality in females in Canada. OS can prevent the most common and lethal type of ovarian cancer, high-grade serous carcinoma (HGSC). OS during gynecologic surgery (hysterectomy or instead of tubal ligation) is safe and effective. However, rates of hysterectomies and tubal sterilization are decreasing. This research team aims to extend the prevention of ovarian cancer by expanding to offer OS during other surgeries in the abdomen, when patients are already undergoing a surgical procedure. This study will examine: 1) the feasibility of OS at the time of laparoscopic cholecystectomy; 2) the safety of OS at the time of laparoscopic cholecystectomy; 3) any health services consequences of offering OBS during laparoscopic cholecystectomy. The hypothesis is that OS at the time of laparoscopic cholecystectomy is a feasible, safe, and cost-effective primary prevention strategy for ovarian cancer. It is also hypothesized that there will be 10-20 minutes of additional operating room time for completing OS, and that integrating the identified partners and knowledge users, as well as adding relevant knowledge users as the project progresses, will affect the rapid mobilization of our findings.

Conditions

Salpingectomy; Laparoscopic Cholecystectomy

Keywords

Salpingectomy; Ovarian Neoplasms; Primary prevention; Cholecystectomy; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (8)

• Feasibility: consent to opportunistic salpingectomy

  The percentage of patients who consented to opportunistic bilateral salpingectomy and went on to successfully have both fallopian tubes removed during their laparoscopic cholecystectomy

  During the surgical intervention (~2 hours for surgical intervention)

• Safety: Length of stay

  Number of days hospitalized from admission time to discharge time

  Within 30 days after surgery

• Safety: 30- day hospital readmission rate

  Indicated by any return to hospital with an inpatient stay in the 30 days following discharge from the surgery

  Within 30 days following discharge from the surgery

• Safety: Blood transfusion rate

  Indicates whether a blood transfusion was required or any other hemostatic agents were used, as measured by any procedure in which whole blood or blood parts are put into a patient's bloodstream through a vein

  During surgery up to 30 days post-surgery

• Safety: Surgical site infection

  Includes any infection that develops at the site of the surgical incision within 30 days that requires further treatment

  Within 30 days after surgery

• Health services outcomes: Duration of Surgery

  The following durations will be examined: (1) OR time required to remove fallopian tubes; (2) Total OR time.

  During surgery

• Health services outcomes: Instruments used during the laparoscopic cholecystectomy

  Instruments used during the laparoscopic cholecystectomy compared to the salpingectomy

  During surgery

• Health services outcomes: Additional ports placed

  Number of additional ports placed during laparoscopic cholecystectomy

  During the surgery

Study Arms (2)

Opportunistic salpingectomy

EXPERIMENTAL

The participating surgeons will attempt to perform bilateral salpingectomy in addition to laparoscopic cholecystectomy.

Procedure: Bilateral salpingectomy; Procedure: Laparoscopic cholecystectomy

Laparoscopic cholecystectomy only

ACTIVE COMPARATOR

Participants will receive the standard of care, which is laparoscopic cholecystectomy.

Procedure: Laparoscopic cholecystectomy

Interventions

Bilateral salpingectomy PROCEDURE

Removal of both fallopian tubes.

Opportunistic salpingectomy

Laparoscopic cholecystectomy PROCEDURE

Removing the gallbladder as indicated by the attending surgeon

Laparoscopic cholecystectomy only; Opportunistic salpingectomy

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with fallopian tubes who are undergoing lap chole and have more than 24 hours from surgeon consult to surgery, regardless of menopausal status
• Age of 35 years and older
• Patient must be able to give oral and written informed consent
• Premenopausal patients will be included but will be counseled regarding their fertility

You may not qualify if:

• Less than 24 hours available from surgeon consult to surgery
• Individuals with a desire for a future pregnancy
• Previously had a salpingectomy or salpingo-oophorectomy

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Cancer Society (CCS): collaborator

Study Sites (3)

Langley Memorial Hospital

Langley, British Columbia, Canada

Location

Vancouver General Hospital (VGH)

Vancouver, British Columbia, Canada

Location

Hamilton Health Sciences Center

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Gillian Hanley, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Heather Stuart, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Scott Cowie, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Pablo Serrano, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gillian Hanley, PhD

CONTACT

778-888-5822; gillian.hanley@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): March 2, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)