Status:
RECRUITING
Water Exchange and CO2 Insufflation with Abdominal Compression Device to Reduce Manual Assistance
Lead Sponsor:
Evergreen General Hospital, Taiwan
Collaborating Sponsors:
E-Da Dachange Hospital, Kaohsiung, Taiwan
The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA
Conditions:
Manual Pressure
Repositioning
Eligibility:
All Genders
45-80 years
Phase:
NA
Brief 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 a...
Detailed Description
This will be a three-arm multicenter parallel randomized controlled trial (RCT) designed to compare the frequency of ancillary manual assistance (abdominal pressure and/or position change) between CO2...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06496958
Start Date
September 2 2024
End Date
September 30 2026
Last Update
November 5 2024
Active Locations (2)
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1
E-Da Dachang Hospital
Kaohsiung City, Taiwan, 807
2
Evergreen General Hospital
Taoyuan District, Taiwan, 320