Using water exchange and CO2 with an abdominal device to ease colonoscopy procedures
CO2 Insufflation Colonoscopy With an Abdominal Compression Device and Water Exchange Colonoscopy to Reduce Manual Assistance by Endoscopy Staff: A Multicenter Randomized Trial
This study is testing if using water and a special device during colonoscopy can help make the procedure easier for patients aged 45-80 without needing as much help from medical staff.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Evergreen General Hospital, Taiwan Academic / other |
| Locations | 2 sites (Kaohsiung City and 1 other locations) |
| Trial ID | NCT06496958 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of water exchange colonoscopy and CO2 insufflation combined with an abdominal compression device in reducing the need for manual assistance during colonoscopic insertion. It is a three-arm multicenter randomized controlled trial comparing CO2 insufflation with the Maxbelt device, CO2 insufflation with a sham device, and water exchange colonoscopy. Patients aged 45-80 at average risk for colorectal cancer will be randomized into one of the three groups to determine which method minimizes the requirement for manual abdominal pressure by endoscopy staff. The study will take place in two hospitals in Taiwan over a period of 30 months.
Who should consider this trial
Good fit: Ideal candidates are patients aged 45-80 years at average risk for colorectal cancer who are scheduled for a sedated outpatient colonoscopy.
Not a fit: Patients with hereditary colorectal cancer syndromes or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to a more comfortable and efficient colonoscopy experience for patients.
How similar studies have performed: Other studies have shown promise in using water exchange techniques for colonoscopy, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 45-80 years having an average risk for colorectal cancer who plan to undergo sedated outpatient colonoscopy for screening, surveillance, and those who have received a positive fecal immunochemical test result Exclusion Criteria: * Patients with hereditary colorectal cancer syndrome, including familial adenomatous polyposis and hereditary nonpolyposis colorectal cancer (Lynch syndrome) * Patients with serrated polyposis syndrome * Patients with known or suspected inflammatory bowel disease * Patients with a history of colorectal cancer or other intra-abdominal malignancy * Patients with a history of colorectal resection * Patients with a history of abdominal aortic aneurysm, cirrhosis, ascites, or other severe comorbid illnesses * Patients with recent wounds or skin rash on the anterior abdominal wall and back * Patients with known ventral hernia * Patients with unsedated procedure * Patients with planned bidirectional endoscopy * Patients with body mass index \>35 kg/m2 * Patients with waist circumference \<55 cm or \>105 cm * Patients with known or suspected gastroparesis * Patients with planned therapeutic procedures (e.g., hemostasis, removal of a large polyp) * Patients with mental retardation * Pregnant women or those planning pregnancy * Patients unwilling to participate in the study
Where this trial is running
Kaohsiung City and 1 other locations
- E-Da Dachang Hospital — Kaohsiung City, Taiwan (Recruiting)
- Evergreen General Hospital — Taoyuan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Chi-Liang Cheng — Evergreen General Hospital
- Study coordinator: Chi-Liang Cheng, MD
- Email: chiliang.cheng@gmail.com
- Phone: +886-919768058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.