Water Exchange (WE) vs. WE Plus Cap-assisted Colonoscopy

Last updated: July 28, 2023
Sponsor: VA Greater Los Angeles Healthcare System
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Colon Cancer Screening

Treatment

Water

cap

Clinical Study ID

NCT03543124
VA
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Water exchange (WE) method has been shown to reduce medication requirement and pain experience during the colonoscopy. Cap-assisted colonoscopy aided by air may also reduced the insertion pain. Therefore, the immediate aim of this study is to assess the generalizability of the impact of WE plus cap (WECAC), as a potentially less painful insertion technique than WE. The control group will use water infusion in lieu of air insufflation during insertion of the colonoscope. The study group will added a cap onto the end of colonoscope during the WE method procedure. This study will also demonstrate if the WECAC method have a shorter insertion time and higher proximal colon adenoma detection rate (ADR) than WE alone in Veterans.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed/educated male and female Veterans undergoing screening, diagnostic orsurveillance colonoscopy at participating sites, choosing scheduled unsedatedcolonoscopy for any reason

Exclusion

Exclusion Criteria:

  • Decline to be randomized
  • Unable to give consent or respond to questionnaires
  • History of colon surgery, active inflammatory bowel disease, lower gastrointestinalbleeding
  • Therapeutic colonoscopy, 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 unsedation 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
  • Medical condition that would preclude a benefit from colonoscopic screening
  • Prosthetic heart valve
  • Anticoagulant therapy
  • Nonmedical problems
  • Need for special precautions in performing colonoscopy
  • Request of on demand sedation

Study Design

Total Participants: 256
Treatment Group(s): 2
Primary Treatment: Water
Phase:
Study Start date:
May 21, 2018
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • VA Palo Alto Healthcare System

    Livermore, California 94550
    United States

    Site Not Available

  • Sacramento VAMC, VA Northern California Healthcare System

    Mather, California 95655-4200
    United States

    Site Not Available

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