Preventing Ovarian Cancer Through Oportunistic Salpingectomy at the Time of Colorectal Surgery

NCT05300711 | Recruiting

• 1 other identifier: H22-003399
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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

Keywords

Salpingectomy; Colorectal Surgery; Ovarian Neoplasms; Primary Prevention

Outcome Measures

Primary Outcomes (4)

• The percentage of participants who consented to OS

  The percentage of participants who were approached who ultimately consented

  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.

  The percentage of participants who consented and underwent removal of both fallopian tubes at the time of their surgery.

  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)

  Average number of minutes spent removing fallopian tubes or attempting to remove fallopian tubes in the situation where removal of both tubes is unsuccessful.

  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.

  Rate of surgical complications among participants undergoing OS at the time of colorectal surgery compared with a control group of patients undergoing colorectal surgery without OS.

  These will be assessed during the surgical intervention and the 30 days following the surgical intervention.

Secondary Outcomes (1)

• Cost-effectiveness of OS as measured by the cost per quality adjusted life year

  Following study completion; an average of 2 years

Study Arms (2)

Opportunistic salpingectomy

EXPERIMENTAL

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

Procedure: Bilateral salpingectomy; Procedure: Colorectal surgery

Colorectal surgery only

ACTIVE COMPARATOR

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

Procedure: Colorectal surgery

Interventions

Bilateral salpingectomy PROCEDURE

Removal of both fallopian tubes.

Opportunistic salpingectomy

Colorectal surgery PROCEDURE

Colorectal surgery as indicated by attending surgeon.

Colorectal surgery only; Opportunistic salpingectomy

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of BRCA 1 or 2 mutation.

Sponsors & Collaborators

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

Study Sites (2)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

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

Study Officials

• Gillian Hanley, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Heather Stuart, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Carl Brown, MD

  St. Paul's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gillian Hanley, PhD

CONTACT

778-888-5822; Gillian.Hanley@vch.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: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 29, 2022
• Study Start: June 20, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)