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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective RCT of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy

Conditions
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Cap, Unsedated Colonoscopy, Water Exchange Colonoscopy, Colonoscopy Pain

Intervention / Treatment
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* Other: Control
* Device: Study method


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Method<br>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<br>* 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.<br>* Other names: Water exchange method;|
| Other: Study Method<br>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<br>* Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.<br>* Other names: Water exchange method plus cap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real Time Maximum Insertion Pain | 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. | Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With No Insertion Pain | Proportion of patients who report no pain during insertion of the colonoscope. | Pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour | 
| Insertion Time | Time to cecum (clock display on monitor), faster insertion is a quality marker | Insertion time in minutes was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour | 
| Right Colon Adenoma Detection Rate (ADR) | Right colon Adenoma Detection Rate (ADR) is the proportion of patients with at least one adenoma in the part of the colon between the cecum and the hepatic flexure. | Adenoma Detection Rate (ADR) was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour | 

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