Water Exchange and CO2 Insufflation With Abdominal Compression Device to Reduce Manual Assistance

NCT06496958 · tracked via the Priya Life Science Taiwan tracker

Sponsor

Evergreen General Hospital, Taiwan

Phase

Not applicable

Started

2024-09-02

Last updated

2026-09-11

Condition(s) studied

Manual PressureRepositioningColonoscopyColon Polyp

Investigational drug(s) / intervention(s)

CO2 insufflation with an abdominal compression deviceCO2 insufflation with a sham abdominal compression deviceWater exchange colonoscopy

CO2 insufflation with an abdominal compression device: For participants randomized to the intervention group, the back brace support belt, Maxbelt (me3 type, Nippon Sigmax Co., Tokyo, Japan), will be applied around the circumference of the lower abdomen. Five sizes of Maxbelt will be employed in this study. According to the manufacturer, the ultra small-size (XS-size) belt will be used in those patients with an abdominal circumference of 55 cm-65 cm, the small-size (S-size) belt will be used in those patients with an abdominal circumference of 65 cm-75 cm, the medium-size (M-size) belt will be used for a circumference of 75 cm-85 cm, the large-size (L-size) belt will be used for a circumference of 85 cm-95 cm, and the ultra large-size (XL-size) will be used for a circumference of 95 cm-105 cm. Once applied, participants will be asked to assess and confirm that the belt is fastened tightly but not uncomfortably.

CO2 insufflation with a sham abdominal compression device: The study coordinator will fit the sham device in a private bay alone with the patient. For participants randomized to the sham control group, a larger-sized Maxbelt with loose fitting will be used as a sham device. The L-size Maxbelt will be used in those patients with an abdominal circumference of 55 cm-71 cm, the XL-size Maxbelt will be used in in those patients with an abdominal circumference of 72 cm-88 cm, and the 2 XL-size Maxbelt will be used in in those patients with abdominal circumference 89 cm-105 cm.

Water exchange colonoscopy: In those patients assigned to the water exchange (WE) group, the air pump will be turned off during the insertion phase of colonoscopy, while the colon is irrigated with warm-to-touch distilled water or half normal saline using a flushing pump. The WE approach involves the simultaneous infusion of water to facilitate luminal expansion and suction of unclean water during insertion. Any encountered air pockets will be aspirated to ensure optimal WE maneuvers in salvage cleaning.

Study 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

Sex

ALL

Min age

45 Years

Max age

80 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Frequency of manual pressure — One day
The proportion of patients who need at least one application of manual abdominal pressure during colonoscopic insertion.

Trial sites (2)

Facility	City	Region	Status
E-Da Dachang Hospital	Kaohsiung City	Taiwan	Recruiting
Evergreen General Hospital	Taoyuan	Taiwan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06496958 on ClinicalTrials.gov ↗ ← All trials in Taiwan