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

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.

Official Title
-----------------
Prospective Randomized Control Trial (RCT) of Water Exchange (WE) vs. WE Plus Cap-assisted Colonoscopy

Conditions
-----------------
Colonoscopy, Real-time Maximum Insertion Pain

Intervention / Treatment
-----------------
* Device: cap
* Other: Water


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Water exchange (WE)<br>This group will have the air in the colon removed and replaced with water to guide the insertion of the colonoscope. | Other: Water<br>* Using water instead air to help insertion<br>|
| Experimental: WE plus cap(WECAC)<br>The procedure of this group is similar with WE group, except a cap will be fitted onto the end of the colonoscope. | Device: cap<br>* A commercially available transparent cap (Olympus) will be fitted to the end of the colonoscope.<br>Other: Water<br>* Using water instead air to help insertion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-time maximum insertion pain(RTMIP) score | 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 | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion with no insertion pain | Proportion report no pain during insertion time. | 2 hours | 
| Insertion time | Time to cecum | 2 hours | 
| Proximal colon ADR | ADR from cecum to splenic flexure | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, pain, water exchange, cap