Prospective Randomized Control Trial (RCT) of Water Exchange (WE) vs. WE Plus Cap-assisted Colonoscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 256
- Locations
- 4
- Primary Endpoint
- Real-time maximum insertion pain(RTMIP) score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
-
- 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.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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 Outcomes
- Insertion time(2 hours)
- Proximal colon ADR(2 hours)
- Proportion with no insertion pain(2 hours)
Investigators
Felix W. Leung
Site PI and Director of Study
VA Greater Los Angeles Healthcare System