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

Randomized Control Trial Comparing the Incidence of Loop Formation in Water Infusion Versus Air Insufflation Colonoscopy Techniques

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colon Cancer Screening
• Intervention / Treatment: Diagnostic test: colonoscopy

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dave Pace, MD; Phone Number: 17096852813; Email: dpace@mun.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colonoscopy with water insufflation; Colonoscopy performed using just water to inflate the colon	Diagnostic test: colonoscopy; Colonoscopy performed using just water or just air to inflate the colon
Experimental: Colonoscopy with air insufflation; Colonoscopy performed using just air to inflate the colon	Diagnostic test: colonoscopy; Colonoscopy performed using just water or just air to inflate the colon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial University of Newfoundland

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: June 9, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Colonoscopy
• Other Study ID Numbers: 41436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No