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Completed

NCT Number: NCT01400087

Cap-attached Colonoscopy Versus Regular Colonoscopy for Trainees

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Digestive Disease Center, Showa University Northern Yokohama Hospital

Yokohama, Kanagawa, 224-8503, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cap-attached Colonoscopy Versus Regular Colonoscopy

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.

Primary outcomes

  1. The success rate of cecal intubation

    Time frame: 24 hours

Secondary outcomes

  1. The procedure time to achieve cecal intubation

    Time frame: 24 hours

  2. Success rate in achieving terminal ileum intubation

    Time frame: 24 hours

  3. The procedure time to achieve terminal ileum intubation

    Time frame: 24 hours

  4. Complications related to the procedure

    Time frame: 24 hours

  5. The dose of the intravenous drugs used

    Time frame: 24 hours

  6. The polyp detection rate

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Showa University

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 22, 2011
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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