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

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.

Conditions

• Manual Pressure
• Repositioning
• Colonoscopy
• Colon Polyp

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• E-Da Dachange Hospital, Kaohsiung, Taiwan

  collaborator UNKNOWN

• The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA

  collaborator UNKNOWN

• Evergreen General Hospital, Taiwan

  lead OTHER

Principal Investigators

• Chi-Liang Cheng · Evergreen General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-09-02

Primary Completion

2026-08-31

Completion

2026-09-30

Countries

• Taiwan

Study Locations