Cap-attached Colonoscopy Versus Regular Colonoscopy for Trainees

Sponsor

Showa University (Other)

Overall Status

Completed

CT.gov ID

NCT01400087

Collaborator

(none)

500

Enrollment

Location

Arms

Actual Duration (Months)

17.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonoscopy Lower Gastrointestinal Tract	Device: Cap-attached Colonoscopy Versus Regular Colonoscopy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Diagnostic

Actual Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cap-attached Colonoscopy	Device: 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.
Placebo Comparator: Regular colonoscopy	Device: 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.

Arm

Intervention/Treatment

Active Comparator: Cap-attached Colonoscopy

Device: 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.

Placebo Comparator: Regular colonoscopy

Device: Cap-attached Colonoscopy Versus Regular Colonoscopy

Outcome Measures

Primary Outcome Measures

The success rate of cecal intubation [24 hours]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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