Dose the Saline Reduce the Mucus Production When Water Exchange Colonoscopy is Used?

Study Overview
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Brief Summary
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This is a study to compare the left colon mucus production between carbon dioxide (CO2) insufflation and water exchange (WE) colonoscopy in patients that require a routine or repeat colonoscopy. There will be four arms in this study: CO2 insufflation (control group 1), WE with water infusion (control group 2), WE with 50% saline infusion (study group 1), and WE with 25% saline infusion (study group 2). 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 WE control group will use sterile water filling during colonoscope insertion. The study method will use saline filling during colonoscopy insertion. This study will confirm if using the saline infusion is a better method in reducing mucus production when WE colonoscopy is used.

Detailed Description
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This will be a single-site (Evergreen General Hospital, Taoyuan, Taiwan), blinded investigators, prospective randomized controlled trial (RCT). Felix W. Leung (from Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System, North Hills, CA) will be involved in the study design, data analysis, and report preparation, but not in patient enrollment. Randomization (CO2, WE with water, WE with 50% saline, WE with 25% saline) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order) 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 different insertion methods with four arms (CO2 insufflation, WE with water, WE with 50% saline, WE with 25% saline) to see which solution used in WE is better in reducing mucus production. Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Randomization will be stratified by investigators and indication of colonoscopy (screening, surveillance, or positive fecal immunochemical test). All participating patients will receive conscious sedation during the colonoscopic examination. Randomization (prepared by statistics consultant) will be carried out by the method of random permuted block design (based on computer generated random numbers) with variable block of 3 and 6. Control method: One arm of the study will include colonoscopy with water infusion during insertion as the control method. Residual air in the colon will be removed and sterile 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. Another arm of the study will include colonoscopy with CO2 insufflation during insertion as an additional control method. Study method: Two arms of the study will include colonoscopy with saline infusion of different strength, i.e., 50% saline and 25% saline, during insertion. Residual air in the colon will be removed and saline solution will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual fecal debris, predominantly during insertion.

Official Title
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Comparing Left Colon Mucus Production by Water Versus Saline Infusion During Water Exchange Colonoscopy: a Prospective Randomized Controlled Trial

Conditions
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Colon Mucous, Colonoscopy

Intervention / Treatment
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* Other: CO2
* Other: Water
* Other: 50% saline
* Other: 25% saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female 20-75 years of age Positive screening for Fecal Immunochemical Test (FIT) Subjects willing to undergo routine screening and surveillance colonoscopy Exclusion Criteria: Patients who decline to provide informed consent Patients known to have colonic obstruction, active inflammatory bowel disease, or active GI bleeding requiring interventions Patients known to have prior history of colonic resection Patients with genetic colorectal syndromes Patients who are scheduled for therapeutic colonoscopy (e.g., hemostasis, removal of large polyp) Patients with American Society of Anesthesiology classification of physical status grade 3 or higher

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CO2 insufflation<br>Colonoscopy will be performed in the traditional fashion, with minimal insufflation required to aid insertion. Cleaning in the CO2 group will be performed entirely during withdrawal. | Other: CO2<br>* using CO2 insufflation to help insertion<br>|
| Active Comparator: WE with water<br>Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual decal debris, predominantly during insertion. | Other: Water<br>* using water instead of traditional gas to help insertion<br>|
| Experimental: WE with 50% saline<br>Residual air in the colon will be removed, 50% salline (1:1 mixture of saline and water) will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual decal debris, predominantly during insertion. | Other: 50% saline<br>* using 50% saline solution instead of traditional gas to help insertion<br>|
| Experimental: WE with 25% saline<br>Residual air in the colon will be removed, 25% saline (1:3 mixture of saline and water) will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual decal debris, predominantly during insertion. | Other: 25% saline<br>* using 25% saline solution instead of traditional gas to help insertion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left colon mucus score | The amount of residual mucus in the left colon (descending colon, sigmoid colon, rectum) is scaled by a mucus score (5-point scale): score 0: no visible mucus; score 1: minimal amounts of clear mucus in thin streaks or strands; score 2: mild opaque mucus in thin strands; score 3: moderate opaque mucus in thicker clumps covering one side of surface; score 4: more opaque mucus in thicker clumps covering more views of lumen. | 2 hours (data collected during colonoscopy procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | The proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas detected | 1.5 years | 
| Cecal intubation | Visualization of ileocecal valve/appendix orifice and the medial wall of the cecum with colonoscope tip touching floor of cecum | 2 hours (data collected during colonoscopy procedure) | 
| Boston Bowel Preparation Scale score | Three segments (Right, transverse, left colon), each with 0 to 3 (poor to excellent); total score = sum (10-point scale) | 2 hours (data collected during colonoscopy procedure) | 
| Cecal intubation time | Total time from insertion into the anus to arrival in the cecum | 2 hours (data collected during colonoscopy procedure) | 
| Withdrawal time | Total time from withdrawal from the cecum to the anus, including cleaning. | 2 hours (data collected during colonoscopy procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Colon Mucus, Water Exchange, Saline