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

NCT07245173 | Not Yet Recruiting

• 1 other identifier: 41436
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number and type of colonscopy loops formed

  The number and type of different colonoscopy loops formed during each colonoscopy will be recorded from the initial insertion of the colonoscope to complete removal of the colonoscope of each colonoscopy.

  12 months

Study Arms (2)

Colonoscopy with water insufflation

EXPERIMENTAL

Colonoscopy performed using just water to inflate the colon

Diagnostic Test: colonoscopy

Colonoscopy with air insufflation

EXPERIMENTAL

Colonoscopy performed using just air to inflate the colon

Diagnostic Test: colonoscopy

Interventions

colonoscopy DIAGNOSTIC_TEST

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

Colonoscopy with air insufflation; Colonoscopy with water insufflation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Memorial University of Newfoundland: lead

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Dave Pace, MD

CONTACT

17096852813; dpace@mun.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Davis Pace

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: November 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share