Randomized Control Trial Comparing the Incidence of Loop Formation in Colonoscopy Techniques

NCT ID: NCT07245173

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-09-30

Brief Summary

A colonoscopy is a common procedure used to check for problems in the colon, such as disease or other health issues. Although it's widely used, one challenge is that the flexible tube used in the procedure (called a colonoscope) can sometimes form loops inside the colon. When this happens, pushing the tube further doesn't help it move forward-it just makes the loop bigger, which can make the procedure harder to complete. These loops can also cause more pain for the patient, require more sedation (medication to relax or put the patient to sleep), and increase the time it takes to finish the procedure. Because of this, it's important to find ways to reduce loop formation. Two common methods used in colonoscopies are called air insufflation and water infusion.

This study will compare the two methods-air vs. water-to see which one causes fewer loops. It will be a randomized controlled trial, meaning participants will be randomly assigned to one of the two methods. The study will involve real patients, and the data will be collected by physicians, residents (doctors in training), and medical students. During the colonoscopies, images from a tool that guides the scope will be recorded on video.

Experienced staff doctors and surgical residents (with at least two months of special training in this procedure) will perform the colonoscopies. Each procedure will be supervised by a team member, such as a medical student, resident, or staff doctor. Afterward, two reviewers who don't know which method was used will watch the videos to look for any loops. They will look for specific types of loops, including n, alpha, reverse alpha, reverse splenic, and gamma loops.

The study will also track how long it takes to reach the end of the colon (called the cecum), how comfortable the patient was (using a standard rating system already used in all colonoscopies), and how much sedation was needed.

Conditions

Colon Cancer Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

Colonoscopy with water insufflation

Colonoscopy performed using just water to inflate the colon

Group Type: EXPERIMENTAL

colonoscopy

Intervention Type: DIAGNOSTIC_TEST

Colonoscopy performed using just water or just air to inflate the colon

Colonoscopy with air insufflation

Colonoscopy performed using just air to inflate the colon

Group Type: EXPERIMENTAL

colonoscopy

Intervention Type: DIAGNOSTIC_TEST

Colonoscopy performed using just water or just air to inflate the colon

Interventions

colonoscopy

Colonoscopy performed using just water or just air to inflate the colon

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Consenting patients who are undergoing a routine colonoscopy.
• Ages between 18-80 years old.

Exclusion Criteria

• Refusal to participate
• Inability to provide informed consent.
• History of prior colonic surgery.
• Poor bowel preparation.
• Known bowel obstruction.
• Emergency colonoscopy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Memorial University of Newfoundland

OTHER

Sponsor Role: lead

Responsible Party

David Pace

Dr. Davis Pace

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Dave Pace, MD

Role: CONTACT

dpace@mun.ca

17096852813

Other Identifiers

41436

Identifier Type: -

Identifier Source: org_study_id