Recruiting

Opportunistic Salpingectomy

Sponsor:

University of British Columbia

Code:

NCT05300711

Conditions

Salpingectomy

Colorectal Surgery

Eligibility Criteria

Sex: Female

Age: 15 - 70+

Healthy Volunteers: Not accepted

Interventions

Bilateral salpingectomy

Colorectal surgery

Study Details

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 colorectal surgery to prevent ovarian cancer. Ovarian cancer is the fifth 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 pelvis where fallopian tubes are accessible, beginning with colorectal surgery. This study will examine: 1) the feasibility of OS at the time of colorectal surgery; 2) the safety of OS at the time of colorectal surgery; 3) the cost-effectiveness of OS at the time of colorectal surgery.

The hypothesis is that OS will be well accepted by individuals with fallopian tubes undergoing colorectal surgery, and that the vast majority (around 90 percent) of attempts to remove both fallopian tubes will be successful. It is expected that there will be 10-20 minutes additional operating room time for completing OS and that there will be no increased risk of complications when OS is included in a colorectal surgery. The researchers also hypothesize that OS at the time of colorectal surgery will be cost-effective because of the reduced number of ovarian cancer cases and associated treatment costs.

Conditions

Salpingectomy

Colorectal Surgery

Study ID

NCT05300711

Start date

Jun 20, 2022

Status verified date

Feb, 2024

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Individuals with intact fallopian tubes.
  • Individuals undergoing one of the following open or laparoscopic colorectal surgery: total colectomy, right hemicolectomy, left hemicolectomy, anterior resection, low anterior resection, small bowel resection and appendectomy.
  • Individuals who finished with childbearing.

Exclusion Criteria:

  • Presence of BRCA 1 or 2 mutation.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Opportunistic salpingectomy

The participating surgeons will attempt to perform bilateral salpingectomy in addition to the colorectal surgery.

active comparator: Colorectal surgery only

Participants will receive the standard of care, that is colorectal surgery.

Interventions

Bilateral salpingectomy

Removal of both fallopian tubes.

Colorectal surgery

Colorectal surgery as indicated by attending surgeon.

Primary outcome measure

  • The percentage of participants who consented to OS [ Time Frame: When the patient is approached and asked to consent and when they decline or consent (~2-4 weeks) ]
  • The percentage of the participants who consented to OS who had both fallopian tubes removed. [ Time Frame: During the surgical intervention (~2 hours for surgical intervention) ]
  • The number of additional minutes in the OR required to attempt or complete opportunistic salpingectomy during colorectal surgery (on average) [ Time Frame: During the surgical intervention, a stopwatch will be started when fallopian removal begins and stopped when it is complete (~20 minutes) ]
  • Incidence of treatment emergent adverse events as assessed by the Clavien Dindo Clavien-Dindo classification of surgical complications. [ Time Frame: These will be assessed during the surgical intervention and the 30 days following the surgical intervention. ]

Central Contacts and Locations

Central contacts

Locations

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

More Information

Sponsor

University of British Columbia

Last update posted

Feb 22, 2024

Last verified

Feb, 2024

Keywords

  • Salpingectomy
  • Colorectal Surgery
  • Ovarian Neoplasms
  • Primary Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-02-22.