Cap-attached Colonoscopy Versus Regular Colonoscopy for Trainees

Study Overview
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Brief Summary
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The aim of this prospective randomized controlled trial is to assess the efficacy of cap-attached colonoscopy to improve cecal intubation in comparison with regular colonoscopy for trainees.

Detailed Description
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Colorectal cancer is one of the major malignancies in western countries and also in Japan. Therefore , the demand for total colonoscopy (TCS) has risen remarkably. However, failure to reach the cecum occurs in up to 10 % of cases. A difficult colonoscopy procedure will often be associated with more complications, and require heavier sedation to alleviate patient's discomfort. Auxiliary devices that could facilitate the examination would be needed. A cap is a simple device that can be attached to the tip of a colonoscope. The advantage of the cap in getting a good view might be helpful in cecal intubation by depressing the folds and also by keeping an appropriate distance between the colonoscope lens and colonic mucosa. We speculated that inexperienced colonoscopists would obtain greater benefit from cap-attached colonoscopy.

Conditions
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Colonoscopy, Lower Gastrointestinal Tract

Intervention / Treatment
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* Device: Cap-attached Colonoscopy Versus Regular Colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who undergo colonoscopy examination Exclusion Criteria: Known to have colonic stricture or obstructing tumor from the results of other investigations such as CT scan or barium enema Presence of acute surgical conditions such as severe colitis, megacolon, ischemic colitis and active gastrointestinal bleeding ・Patients who diagnosed as inflammatory bowel disease

Ages Eligible for Study
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Minimum Age: 18 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cap-attached Colonoscopy<br> | Device: Cap-attached Colonoscopy Versus Regular Colonoscopy<br>* Trainees were divided into two group; Cap-attached Colonoscopy group or Regular Colonoscopy group. Trainees allocated to the former group undergo colonoscopy with cap for all cases, the latter without cap.<br>|
| Placebo Comparator: Regular colonoscopy<br> | Device: Cap-attached Colonoscopy Versus Regular Colonoscopy<br>* Trainees were divided into two group; Cap-attached Colonoscopy group or Regular Colonoscopy group. Trainees allocated to the former group undergo colonoscopy with cap for all cases, the latter without cap.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of cecal intubation |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The procedure time to achieve cecal intubation |  | 24 hours | 
| Success rate in achieving terminal ileum intubation |  | 24 hours | 
| The procedure time to achieve terminal ileum intubation |  | 24 hours | 
| Complications related to the procedure |  | 24 hours | 
| The dose of the intravenous drugs used |  | 24 hours | 
| The polyp detection rate |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, Lower Gastrointestinal Tract, Cecal intubation, Cap-attached colonoscopy, Trainee