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Procedure

Opportunistic Salpingectomy During Colorectal Surgery

N/A

Recruiting

Led By Heather Stuart, MD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up following study completion; an average of 2 years

Awards & highlights

Study Summary

This trial will test whether it is feasible and safe to do a common cancer-preventing surgery, salpingectomy, during another surgery where the fallopian tubes are accessible. If so, this would be a low-cost way to help prevent a cancer with few symptoms and a high death rate.

Who is the study for?

This trial is for people with intact fallopian tubes who are having certain types of colorectal surgery (like total colectomy or appendectomy) and have completed childbearing. It's not for those with BRCA 1 or 2 mutations.Check my eligibility

What is being tested?

The study tests the addition of a procedure called opportunistic salpingectomy, which removes the fallopian tubes, to routine colorectal surgeries to see if it can prevent ovarian cancer without adding risks.See study design

What are the potential side effects?

While specific side effects aren't listed, the trial expects no increased risk of complications from adding salpingectomy to colorectal surgery. Any additional side effects would likely be related to standard surgical risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My fallopian tubes are intact.

Select...

I am having surgery for my colon or small bowel.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ following study completion; an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~following study completion; an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and following study completion; an average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of treatment emergent adverse events as assessed by the Clavien Dindo Clavien-Dindo classification of surgical complications.

The number of additional minutes in the OR required to attempt or complete opportunistic salpingectomy during colorectal surgery (on average)

The percentage of participants who consented to OS

+1 more

Secondary outcome measures

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Opportunistic salpingectomyExperimental Treatment2 Interventions

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

Group II: Colorectal surgery onlyActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Colorectal surgery

2012

N/A

~750

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,466,878 Total Patients Enrolled

Canadian Cancer Society (CCS)OTHER

78 Previous Clinical Trials

37,505 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,527 Total Patients Enrolled

Media Library

Colorectal Surgery (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05300711 — N/A

Colorectal Surgery Research Study Groups: Opportunistic salpingectomy, Colorectal surgery only

Colorectal Surgery Clinical Trial 2023: Colorectal Surgery Highlights & Side Effects. Trial Name: NCT05300711 — N/A

Colorectal Surgery (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05300711 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any slots still available for participants in this experiment?

"According to the details published on clinicaltrials.gov, this trial is presently seeking candidates. The initial posting was made June 20th 2022 and it has since been amended as recently as June 28th 2022."

Answered by AI

Is this experiment permissible for geriatric participants?

"To be eligible for this research, prospective participants must fall between the ages of 15 and 80. Additionally, there are two trials designed specifically to include minors aged 18 or below as well as a further 14 studies focusing on individuals 65 years old or above."

Answered by AI

How many individuals are engaged in the research being done on this subject?

"Affirmative. The clinical trial's listing on clinicaltrials.gov states that the study, which was initially posted on June 20th 2022, is presently seeking enrollees from 1 location and requires 240 subjects in total."

Answered by AI

May I take part in this experiment?

"This clinical trial is looking to enrol 240 participants aged 15-80 that are scheduled for a colorectal surgery. Candidates must have intact fallopian tubes, and the procedure must be one of the following: total colectomy, right hemicolectomy, left hemicolectomy, anterior resection, low anterior resection, small bowel resection or appendectomy. Furthermore individuals should already have completed their childbearing journey."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Gillian Hanley 2022. "Preventing Ovarian Cancer Through Oportunistic Salpingectomy at the Time of Colorectal Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05300711.