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

November 3, 2024 updated by: Evergreen General Hospital, Taiwan

CO2 Insufflation Colonoscopy with an Abdominal Compression Device and Water Exchange Colonoscopy to Reduce Manual Assistance by Endoscopy Staff: a Multicenter Randomized 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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-insufflation colonoscopy with Maxbelt (intervention group), CO2-insufflation colonoscopy with sham device (sham control group), and water exchange (WE) colonoscopy (WE group). Enrolled patients will be randomized in a 1:1:1 ratio to either the intervention, sham control, or WE group. This will be a comparison of three different methods (CO2 with interventional device, CO2 with sham device, WE) to see which one is better at decreasing the need for manual assistance by endoscopy staff during colonoscopic insertion.

This study will be conducted in two hospitals in Taiwan: Evergreen General Hospital at Taoyuan and E-Da Dachange Hospital at Kaohsiung. The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA will be a non-recruiting participating site. This planned RCT will span 30 months (from June 2024 to November 2026), including 3 months for the initial setup and 3 months for the final analysis. The study site possesses state-of-the-art colonoscopy equipment setups, and the investigators are WE colonoscopy research experts.

Patients aged 45-75 y/o at average risk of colorectal cancer who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified by investigator and type of colonoscopy (screening, surveillance, or positive fecal immunochemical test result). Mode of sedation will include conscious sedation (fentanyl plus midazolam) or full sedation (propofol with fentanyl plus midazolam) . Randomization will be carried out by computer-generated sequences using a block design (four participants per block).

CO2 with interventional device group: The Maxbelt will be applied around the circumference of the lower abdomen just below the umbilicus based on patient's abdominal circumference. Five sizes of Maxbelt will be employed in this study: XS-size for 55-65 cm circumference, S-size for 65-75 cm circumference, M-size for 75-85 cm circumference, L-size for 85-95 cm circumference, and XL-size for 95-105 cm circumference. Once applied, participants will be asked to assess and confirm that the belt is fastened tightly but not uncomfortably.

CO2 with sham device group: A two-size larger Maxbelt with loose fitting will be used as a sham device: L-size will be used for 55-71 cm circumference, XL-size will be used for 72-88 cm circumference, and 2 XL-size will be used for 89-105 cm circumference.

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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Recruiting
        • E-Da Dachang Hospital
        • Contact:
        • Contact:
          • Jen-Hao Jeh, MD
      • Taoyuan, Taiwan, 320
        • Recruiting
        • Evergreen General Hospital
        • Contact:
        • Contact:
          • Chi-Liang Cheng, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CO2 insufflation colonoscopy with an abdominal compression device
Colonoscopic insertion will be performed with CO2 insufflation with assistance by an abdominal compression device.
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.
Sham Comparator: CO2 insufflation colonoscopy with a sham abdominal compression device
Colonoscopic insertion will be performed with CO2 insufflation in standard method. A sham abdominal compression device will be used as a sham comparator.
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.
Active Comparator: Water exchange colonoscopy
Colonoscopic insertion will be performed with water exchange method.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of manual pressure
Time Frame: One day
The proportion of patients who need at least one application of manual abdominal pressure during colonoscopic insertion.
One day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of repositioning
Time Frame: One day
The proportion of patients who need at least one application of position change during colonoscopic insertion.
One day
Ergonomic pain of after colonoscopy
Time Frame: One day
The musculoskeletal pain experienced by the assisting nurse will be reported based on a 5-point visual analogue scale score immediately after a procedure by using a questionnaire.
One day
Colonoscopy difficulty
Time Frame: One day
The colonoscopy difficulty assessed by the endoscopist will be reported using a 5-point visual analogue scale score immediately after completion of the procedure by using a questionnaire.
One day
Post-colonoscopy abdominal pain
Time Frame: One day
The pain experienced by the patient will be recorded in the recovery room post-procedure via a questionnaire using a 5-point visual analogue scale score.
One day
Cecal intubation time
Time Frame: One day
The cecal intubation time is defined as the time spanning from anal insertion to colonoscopic intubation of cecum.
One day
Withdrawal time
Time Frame: One day
The withdrawal time is defined as the time spanning from cecal intubation to colonoscope withdrawal from the anus.
One day
Adenoma detection rate
Time Frame: One week (after the colonoscopy procedure, when pathology report is released)
The proportion of patients with at least one conventional adenoma of any size.
One week (after the colonoscopy procedure, when pathology report is released)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evergreen General Hospital, Taiwan

Collaborators

The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA
E-Da Dachange Hospital, Kaohsiung, Taiwan

Investigators

  • Principal Investigator: Chi-Liang Cheng, Evergreen General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

July 4, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 3, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGH-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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