Water Exchange and CO2 Insufflation With Abdominal Compression Device to Reduce Manual Assistance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorEvergreen General Hospital, Taiwan
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CO2 insufflation with an abdominal compression device
- CO2 insufflation with a sham abdominal compression device
- Water exchange colonoscopy
Treatment groups
400 Participants
are divided into 3 treatment groupsSponsors and collaborators
Evergreen General Hospital, Taiwan
Lead sponsor
E-Da Dachange Hospital, Kaohsiung, Taiwan
Collaborator
The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA
Collaborator
Source ClinicalTrials.gov