Cap-attached Colonoscopy Versus Regular Colonoscopy for Trainees

Not Applicable

Completed

• Conditions: Colonoscopy; Lower Gastrointestinal Tract
• Interventions: Device: Cap-attached Colonoscopy Versus Regular Colonoscopy

• Registration Number: NCT01400087
• Lead Sponsor: Showa University

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-21
• Study First Posted: 2011-07-22
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cap-attached Colonoscopy	Cap-attached Colonoscopy Versus Regular Colonoscopy	-
Regular colonoscopy	Cap-attached Colonoscopy Versus Regular Colonoscopy	-

Primary Outcome Measures

Name	Time	Method
The success rate of cecal intubation	24 hours

Secondary Outcome Measures

Name	Time	Method
The polyp detection rate	24 hours
The procedure time to achieve cecal intubation	24 hours
The procedure time to achieve terminal ileum intubation	24 hours
The dose of the intravenous drugs used	24 hours
Success rate in achieving terminal ileum intubation	24 hours
Complications related to the procedure	24 hours

Trial Locations

Locations (1)

Digestive Disease Center, Showa University Northern Yokohama Hospital; 🇯🇵 Yokohama, Kanagawa, Japan