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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03543124
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : October 8, 2019
Sponsor:
Collaborators:
VA Palo Alto Health Care System
VA Northern California Health Care System
Information provided by (Responsible Party):
Felix W. Leung, VA Greater Los Angeles Healthcare System

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
Colonoscopy Real-time Maximum Insertion Pain Device: cap Other: Water Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
  1. 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.
  2. 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
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Real-time maximum insertion pain(RTMIP) score [ Time Frame: 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 [ Time Frame: 2 hours ]
    Proportion report no pain during insertion time.

  2. Insertion time [ Time Frame: 2 hours ]
    Time to cecum

  3. Proximal colon ADR [ Time Frame: 2 hours ]
    ADR from cecum to splenic flexure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543124


Contacts
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Contact: Nora Jamgotchian, MS 818-895-9426 Nora.Jamgotchian@va.gov
Contact: Felix W Leung, MD 818-891-7711 ext 32520 felix.leung@va.gov

Locations
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United States, California
VA Palo Alto Healthcare System Recruiting
Livermore, California, United States, 94550
Contact: Shai Friedland, MD       shai_friedland@yahoo.com   
Contact: Ramsey Cheung, MD       ramsey.Cheun@va.gov   
Sacramento VAMC, VA Northern California Healthcare System Recruiting
Mather, California, United States, 95655-4200
Contact: Andrew Yen, MD       andrew.yen3@va.gov   
Contact: Joseph W Leung, MD       Joseph.Leung@va.gov   
Sponsors and Collaborators
VA Greater Los Angeles Healthcare System
VA Palo Alto Health Care System
VA Northern California Health Care System
Investigators
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Principal Investigator: Felix W Leung, MD VA Greater Los Angeles Healthcare System

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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: June 1, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Felix W. Leung, VA Greater Los Angeles Healthcare System:
colonoscopy
pain
water exchange
cap