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Recruiting
NCT06496958
Water Exchange and CO2 Insufflation With Abdominal Compression Device to Reduce Manual Assistance
Conditions: Manual Pressure, Repositioning, Colonoscopy, Colon Polyp
Sex: All
Ages: 45 Years – 80 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 400
Sponsor: Evergreen General Hospital, Taiwan
Location: E-Da Dachang Hospital Kaohsiung City
Summary
The goal of this trial is to evaluate whether water exchange colonoscopy and CO2-insufflation colonoscopy with an abdominal compression device (Maxbelt me3 type, Nippon Sigmax Co., Tokyo, Japan) can achieve a significantly lower proportion of patients requiring manual abdominal pressure during colonoscopic insertion compared with CO2 insufflation alone.
Eligibility 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 \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
Source: ClinicalTrials.gov (NCT06496958). StuddyBuddy aggregates publicly available trial information.