Text Size

Cap-attached Colonoscopy Versus Regular Colonoscopy for Trainees

This study is currently recruiting participants.
Verified June 2011 by Showa University
Sponsor:
Information provided by:
Showa University
ClinicalTrials.gov Identifier:
NCT01400087
First received: July 21, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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 Intervention
Colonoscopy
Lower Gastrointestinal Tract
 Device: Cap-attached Colonoscopy Versus Regular Colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Showa University:

Primary Outcome Measures:
  • The success rate of cecal intubation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The procedure time to achieve cecal intubation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Success rate in achieving terminal ileum intubation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The procedure time to achieve terminal ileum intubation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Complications related to the procedure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The dose of the intravenous drugs used [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The polyp detection rate [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: June 2011
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400087

Contacts
Contact: Makoto Kutsukawa kutsumakomako@yahoo.co.jp

Locations
Japan
Digestive Disease Center, Showa University Northern Yokohama Hospital Recruiting
Yokohama, Kanagawa, Japan, 224-8503
Contact: Makoto Kutsukawa         kutsumakomako@yahoo.co.jp    
Principal Investigator: Shin-ei Kudo            
Sponsors and Collaborators
Showa University
Investigators
Principal Investigator: Shin-ei Kudo Digestive Disease Center, Showa University Northern Yokohama Hospital
  More Information

Publications:

Responsible Party: Shin-ei Kudo, Digestive Disease Center, Showa University Northern Yokohama Hospital
ClinicalTrials.gov Identifier: NCT01400087     History of Changes
Other Study ID Numbers: CAPSTUDY
Study First Received: July 21, 2011
Last Updated: July 21, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by Showa University:
colonoscopy
Lower Gastrointestinal Tract
Cecal intubation
Cap-attached colonoscopy
Trainee

ClinicalTrials.gov processed this record on May 19, 2013