Preventing Ovarian Cancer Through the Expansion of Opportunistic Salpingectomy: Uptake, Safety and Cost-effectiveness at the Time of Colorectal Surgery

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 15
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
St. Paul's Hospital
RECRUITING
Vancouver
Vancouver General Hospital
NOT_YET_RECRUITING
Vancouver
Contact Information
Primary
Gillian Hanley, PhD
Gillian.Hanley@vch.ca
778-888-5822
Time Frame
Start Date: 2022-06-20
Estimated Completion Date: 2026-03
Participants
Target number of participants: 240
Treatments
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.
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Canadian Cancer Society (CCS)
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov