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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07245173
Enrollment
142
Registered
2025-11-24
Start date
2026-01-01
Completion date
2027-09-30
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer Screening

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.

Interventions

DIAGNOSTIC_TESTcolonoscopy

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

Sponsors

Memorial University of Newfoundland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number and type of colonscopy loops formed12 monthsThe 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.

Contacts

Primary ContactDave Pace, MD
dpace@mun.ca17096852813

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026