Using water exchange and CO2 with an abdominal device to ease colonoscopy procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.