CO2 Insufflation Colonoscopy With an Abdominal Compression Device and Water Exchange Colonoscopy to Reduce Manual Assistance by Endoscopy Staff: A Multicenter Randomized Trial

What this Trial Is About

Researchers are evaluating three different methods of colonoscopy insertion to see which one reduces the need for manual abdominal pressure by endoscopy staff. The trial focuses on patients aged 45 to 80 years at average risk for colorectal cancer undergoing sedated outpatient colonoscopy for screening, surveillance, or following a positive fecal immunochemical test. This multicenter randomized controlled trial compares water exchange colonoscopy and CO2-insufflation colonoscopy with an abdominal compression device against CO2 insufflation alone with a sham device. Participants will be randomly assigned to one of three groups: CO2 insufflation colonoscopy with the Maxbelt abdominal compression device, CO2 insufflation colonoscopy with a sham abdominal compression device, or water exchange colonoscopy. The Maxbelt device will be fitted according to abdominal circumference in the intervention group, while the sham group will use a larger, loosely fitted belt. The water exchange group will have the air pump turned off during insertion, with warm distilled water or half saline used to irrigate the colon. The study will last 30 months, including setup and final analysis. During the study, participants will undergo the chosen colonoscopy method with sedation as appropriate. Researchers will track the frequency of manual abdominal pressure and repositioning needed, ergonomic pain after colonoscopy, procedure difficulty, abdominal pain post-procedure, cecal intubation time, withdrawal time, and adenoma detection rate. Assessments will occur on the day of colonoscopy and one week later when pathology reports are available. The trial includes close monitoring and uses a triple-blind design to ensure objective evaluation.

Water Exchange and CO2 Insufflation With Abdominal Compression Device to Reduce Manual Assistance