Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy

Study Overview
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Brief Summary
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Patients with colorectal adenomas are suggested to receive polypectomy. A substantial number of adenomas may be missed in patients with polyps found by previous colonoscopy. And water exchange (WE) method may increase the detection of missed adenoma compared with traditional air insufflation (AI) colonoscopy. The investigators aim to investigate whether water exchange colonoscopy method, compared with air insufflation method, can improve the detection of missed adenomas in patients undergoing selective polypectomy.

Detailed Description
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For WE method, the air pump was turned off for the full duration of insertion to avoid inadvertent air insufflations and colon elongation. Residual air in the lumen was suctioned to minimize angulations at flexures. Water at 37°C was infused with a pump (Olympus) through the biopsy channel to confirm correct tip orientation for scope advancement. The infused water was removed predominantly by suction when the colonoscope was smoothly advanced during the insertion phase, and turbid luminal water due to residual feces was exchanged by clean water until the lumen was clearly visualized. Occasionally, if it was difficult to determine whether the colonoscope tip was in the cecum, air was allowed to be insufflated for observation. If the position of the scope tip was confirmed to be not in the cecum, insufflated air would be removed by suction and the WE method would be continuously used until successful intubation. For the AI method, water was not used, and air was insufflated during insertion. Air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal for both methods. Polyps will be removed by forceps biopsy (polyps size <3mm), cold snare technique (3-6mm) or endoscopic mucosal resection (size≥6mm).

Official Title
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Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy: a Single-centered, Randomized Controlled Study

Conditions
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Adenoma

Intervention / Treatment
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* Other: Water exchange (WE) method
* Other: Air insufflation (AI) method.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 patients undergoing selective polypectomy Exclusion Criteria: Polyps found more than 6 months Patients with polyposis syndrome or hereditary nonpolyposis colorectal cancer Patients with history of inflammatory bowel disease Patients with planning to undergo Endoscopic Submucosal Dissection(ESD) Patients not undergoing standard bowel preparation Patients with solid feces in the last stool after bowel preparation Patients considered to be high risk for bleeding during Endoscopic mucosal resection (EMR), e.g. using antiplatelet drugs (clopidogrel) within 5 days before the current colonoscopy Hemodynamically unstable Pregnant women Unable to provide informed consent

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Water exchange (WE) method<br>Water exchange (WE) method was used for insertion to the cecum. | Other: Water exchange (WE) method<br>* Water exchange (WE) method was used for insertion to the cecum. And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.<br>|
| Active Comparator: Air insufflation (AI) method<br>Air insufflation (AI) method was used for insertion to the cecum. | Other: Air insufflation (AI) method.<br>* Air insufflation (AI) method was used for insertion to the cecum. And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma miss rate | Adenoma miss rate was calculated as the number of patients with one and more additional adenomas during polypectomy procedure divided by the total number of patients in each group. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adenoma-level miss rate | Adenoma-level miss rate was calculated as the number of additional adenomas detected in polypectomy procedure divided by the total number of adenomas in each group. | 12 months | 
| Advanced adenoma miss rate/Miss advanced adenoma per colonoscopy | Advanced adenoma: any with 3 or more adenomas of any size, 1 or more large adenomas 1 cm, or 1 or more adenomas with villous architecture or highgrade dysplasia. | 12 months | 
| Adenoma per positive patient (APP) | The mean number of adenoma per positive patient | 12 months | 
| Quality of Bowel Preparation | The Boston Bowel Preparation Scale (BBPS): cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid. | 12 months | 
| Complication rate | Bleeding, perforation and others | 12 months | 
| Pain Scores on the Visual Analog Scale compared with previous colonoscopy | 0 = no pain, to 10 = most severe pain | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Water exchange colonoscopy, Adenoma miss rate, Polyps