RecruitingNot ApplicableNCT06496958

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

CO2 Insufflation Colonoscopy With an Abdominal Compression Device and Water Exchange Colonoscopy to Reduce Manual Assistance by Endoscopy Staff: A Multicenter Randomized Trial

Sponsor

Evergreen General Hospital, Taiwan

Enrollment

400 participants

Start Date

Sep 2, 2024

Study Type

INTERVENTIONAL

Conditions

Colonoscopy Colon Polyp Manual Pressure Repositioning

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

Min Age: 45 YearsMax Age: 80 Years

Inclusion Criteria1

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 Criteria17

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

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Interventions

DEVICECO2 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.

DEVICECO2 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.

DEVICEWater 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.