Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy

November 17, 2023 updated by: VA Office of Research and Development

Prospective RCT of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy

This is a study to compare two different, but normally, used methods of colonoscopy in patients undergoing colonoscopy without sedation. There will be two arms in this study: WE (water exchange) control, and WE (water exchange) plus cap (placed at tip of the colonoscope). The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The control method will use water instead of air during insertion of the colonoscope. The study method will use a cap that will fit onto the end of the colonoscope plus water during insertion of the colonoscope. This study will assess if the study method is less painful than the control method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a multi-VA site, unblinded investigators, prospective randomized control trial (RCT). Randomization (WE, WE + cap) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order set up by statistics consultant) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two arms (WE, WE + cap) to see which one is less painful.

Patients 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 type of colonoscopy (screening, surveillance, diagnostic). All subjects will have scheduled unsedated colonoscopy as a result of lack of escort or personal preference for no sedation. Randomization will be set up by statistics consultant.

Control Method: One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.

Study method: The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a cap, fitted to the colonoscope per manufacturer instruction.

Study Type

Interventional

Enrollment (Actual)

280

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 Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304-1290
        • VA Palo Alto Health Care System, Palo Alto, CA
      • Sacramento, California, United States, 95655
        • VA Northern California Health Care System, Mather, CA
      • Sepulveda, California, United States, 91343
        • VA Greater Los Angeles Healthcare System, Sepulveda, CA

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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Informed/educated (about pros and cons of the unsedated option) Veterans undergoing:

    • diagnostic
    • surveillance (follow up of polyps)
    • screening (first-time) colonoscopy at participating sites
    • choosing scheduled unsedated colonoscopy for any reason (lack of escort, personal preference)

Exclusion Criteria:

  • decline to be randomized
  • unable to give consent or respond to questionnaires
  • history of colon surgery
  • active inflammatory bowel disease
  • lower gastrointestinal bleeding (except for occult blood or FIT positive in the context of colon cancer screening)
  • therapeutic colonoscopy (e.g., hemostasis, removal of large polyp)
  • proctosigmoidoscopy
  • bidirectional endoscopy
  • inadequate consumption of bowel preparation
  • known history of severe diverticulosis or diverticulitis
  • history of abdominal surgery previously requiring sedation for colonoscopy
  • current narcotic/anxiolytic medication use
  • prior unsuccessful experience with unsedated colonoscopy
  • emergent colonoscopy
  • evidence of colonic obstruction based on pre-colonoscopy clinical evaluation
  • current participation in other studies

  • medical condition that could increase the risk associated with colonoscopy

    • active cardiac
    • or pulmonary disease
    • or other serious disease

  • medical condition that would preclude a benefit from colonoscopic screening

    • cancer
    • or any terminal illness
  • prosthetic heart valve
  • anticoagulant therapy

  • nonmedical problems

    • psychiatric disorders
    • excessive use of alcohol

  • need for special precautions in performing colonoscopy

    • antibiotic prophylaxis
  • request of on demand sedation

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Method
One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Other: Control
Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.
Other Names:
  • Water exchange method
Other: Study Method
The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Device: Study method
Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.
Other Names:
  • Water exchange method plus cap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real Time Maximum Insertion Pain
Time Frame: Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Pain during insertion reported to the unblinded assisting nurse, visual analogue scale, VAS: 0=none, 10=most severe. The highest pain score will be tabulated for analysis. Timing of data collection will be at the discretion of the nurse to minimize bias by colonoscopist behavior.
Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients With No Insertion Pain
Time Frame: Pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Proportion of patients who report no pain during insertion of the colonoscope.
Pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Insertion Time
Time Frame: Insertion time in minutes was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Time to cecum (clock display on monitor), faster insertion is a quality marker
Insertion time in minutes was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Right Colon Adenoma Detection Rate (ADR)
Time Frame: Adenoma Detection Rate (ADR) was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Right colon Adenoma Detection Rate (ADR) is the proportion of patients with at least one adenoma in the part of the colon between the cecum and the hepatic flexure.
Adenoma Detection Rate (ADR) was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour

Collaborators and Investigators

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

Sponsor

VA Office of Research and Development

Collaborators

VA Palo Alto Health Care System
VA Northern California Health Care System

Investigators

  • Principal Investigator: Felix W. Leung, MD, VA Greater Los Angeles Healthcare System, Sepulveda, CA

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)

June 8, 2018

Primary Completion (Actual)

October 28, 2022

Study Completion (Actual)

October 28, 2022

Study Registration Dates

First Submitted

May 12, 2017

First Submitted That Met QC Criteria

May 18, 2017

First Posted (Actual)

May 19, 2017

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GAST-015-16S

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

Yes

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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