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Trial record 6 of 145 for:    Recruiting, Not yet recruiting, Available Studies | "Drinking Water"

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

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ClinicalTrials.gov Identifier: NCT03160859
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : June 11, 2018
Sponsor:
Collaborators:
VA Northern California Health Care System
VA Palo Alto Health Care System
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Unsedated Colonoscopy Water Exchange Colonoscopy Cap Colonoscopy Pain Other: Control Device: Study method Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a multi-VA site, prospective RCT to compare different methods with 2 arms to determine which is less painful: water alone or water plus cap. Randomization will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. 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. Control Method: Involves unsedated colonoscopy with water exchange. Residual air 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: Involves unsedated colonoscopy with water exchange and the addition of a commercially available accessory fitted onto the colonoscope.
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Prospective RCT of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy
Actual Study Start Date : June 8, 2018
Estimated Primary Completion Date : April 29, 2022
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Water exchange method

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 Name: Water exchange method plus cap




Primary Outcome Measures :
  1. Primary Outcome Variable: Real time maximum insertion pain [ Time Frame: 48 months ]
    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.


Secondary Outcome Measures :
  1. Secondary Outcome Variables: Proportion with no insertion pain [ Time Frame: 48 months ]
    Proportion report no pain during insertion of the colonoscope (quality marker)

  2. Secondary Outcome Measure: Insertion time [ Time Frame: 48 months ]
    Time to cecum (clock display on monitor), faster insertion is a quality marker

  3. Secondary Outcome Measure: Proximal colon ADR [ Time Frame: 48 months ]
    ADR from cecum to splenic flexure, measure of high quality colonoscopy



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 (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

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): NCT03160859


Contacts
Contact: Felix W Leung, MD (818) 891-7711 Felix.Leung@va.gov
Contact: Nora J Jamgotchian, MS BA (818) 895-9426 nora.jamgotchian@va.gov

Locations
United States, California
VA Palo Alto Health Care System, Palo Alto, CA Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Shai Friedland, MD       shai_friedland@yahoo.com   
Contact: Ramsey Cheung, MD       rcheung@stanford.edu   
VA Northern California Health Care System, Mather, CA Recruiting
Sacramento, California, United States, 95655
Contact: Andrew W Yen, MD       Andrew.Yen3@va.gov   
Contact: Joseph W Leung, MD       Joseph.Leung@va.gov   
VA Greater Los Angeles Healthcare System, Sepulveda, CA Recruiting
Sepulveda, California, United States, 91343
Contact: Dean T Yamaguchi, MD    310-268-4437    Dean.Yamaguchi@va.gov   
Principal Investigator: Felix W. Leung, MD         
Sponsors and Collaborators
VA Office of Research and Development
VA Northern California Health Care System
VA Palo Alto Health Care System
Investigators
Principal Investigator: Felix W. Leung, MD VA Greater Los Angeles Healthcare System, Sepulveda, CA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03160859     History of Changes
Other Study ID Numbers: GAST-015-16S
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
unsedated colonoscopy
water exchange colonoscopy
cap
colonoscopy pain