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

Sponsor
VA Greater Los Angeles Healthcare System (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT03543124
Collaborator
VA Palo Alto Health Care System (U.S. Fed), VA Northern California Health Care System (U.S. Fed)
256
Enrollment
2
Locations
2
Arms
55.4
Anticipated Duration (Months)
128
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: cap
  • Other: Water
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
256 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
1) The patients will not be informed of the technique, and what the cap at the tip looks like; 2) The colonoscope will be set up in the absence of the patient; 3) Before the start, a small towel will cover the eye of the patients, and care will be taken not to uncover the eyes when the patient is moved. There will be a preliminary statistical analysis of the coded data, followed by a complete review by the assessor, who will conduct the final analysis.
Primary Purpose:
Other
Official Title:
Prospective Randomized Control Trial (RCT) of Water Exchange (WE) vs. WE Plus Cap-assisted Colonoscopy
Actual Study Start Date :
May 21, 2018
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Water exchange (WE)

This group will have the air in the colon removed and replaced with water to guide the insertion of the colonoscope.

Other: Water
Using water instead air to help insertion
Experimental: WE plus cap(WECAC)

The procedure of this group is similar with WE group, except a cap will be fitted onto the end of the colonoscope.

Device: cap
A commercially available transparent cap (Olympus) will be fitted to the end of the colonoscope.

Other: Water
Using water instead air to help insertion

Outcome Measures

Primary Outcome Measures

  1. Real-time maximum insertion pain(RTMIP) score [2 hours]

    Pain during insertion reported to the unblinded assisting nursing, visual analogue scale (VAS): 0=no pain, 10=most severe pain. 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

Secondary Outcome Measures

  1. Proportion with no insertion pain [2 hours]

    Proportion report no pain during insertion time.

  2. Insertion time [2 hours]

    Time to cecum

  3. Proximal colon ADR [2 hours]

    ADR from cecum to splenic flexure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Informed/educated male and female Veterans undergoing screening, diagnostic or surveillance colonoscopy at participating sites, choosing scheduled unsedated colonoscopy for any reason
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

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA Palo Alto Healthcare System Livermore California United States 94550
2 Sacramento VAMC, VA Northern California Healthcare System Mather California United States 95655-4200

Sponsors and Collaborators

  • VA Greater Los Angeles Healthcare System
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Felix W. Leung, Site PI and Director of Study, VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier:
NCT03543124
Other Study ID Numbers:
  • VA
First Posted:
Jun 1, 2018
Last Update Posted:
Feb 2, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Felix W. Leung, Site PI and Director of Study, VA Greater Los Angeles Healthcare System
colonoscopy
pain
water exchange
cap

Study Results

No Results Posted as of Feb 2, 2022