Preventing Ovarian Cancer Through Oportunistic Salpingectomy at the Time of Colorectal Surgery
NCT05300711 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2024-02-22
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
Interventions
- PROCEDURE
-
Bilateral salpingectomy
Removal of both fallopian tubes.
- PROCEDURE
-
Colorectal surgery
Colorectal surgery as indicated by attending surgeon.
Sponsors & Collaborators
-
Canadian Cancer Society (CCS)
collaborator OTHER -
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
University of British Columbia
lead OTHER
Principal Investigators
-
Gillian Hanley, PhD · University of British Columbia
-
Heather Stuart, MD · University of British Columbia
-
Carl Brown, MD · St. Paul's Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 80 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-20
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
Countries
- Canada
Study Locations
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