Cap-attached Colonoscopy Versus Regular Colonoscopy for Trainees

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-11-30

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.

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cap-attached Colonoscopy

Group Type ACTIVE_COMPARATOR

Cap-attached Colonoscopy Versus Regular Colonoscopy

Intervention Type DEVICE

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.

Regular colonoscopy

Group Type PLACEBO_COMPARATOR

Cap-attached Colonoscopy Versus Regular Colonoscopy

Intervention Type DEVICE

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.

Interventions

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Cap-attached Colonoscopy Versus Regular Colonoscopy

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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No