Use of Magnetic Imaging to Asses the Efficacy of Cap Assisted Colonoscopy in Reducing Looping and Improving Patient Acceptance for the Colonoscopy Procedure

March 25, 2010 updated by: Chinese University of Hong Kong

A Double-Blinded Randomized Study Comparison the Mechanism of Looping Formation and Subject's Acceptance During CAC and Regular Colonoscopy by MEI (MIC Study)

The aim of this study is to compare the mechanism of loop formation and acceptance of CAC and regular colonoscopy by MEI.

Study Overview

Status

Withdrawn

Conditions

Colonoscopy

Intervention / Treatment

Procedure: MEI

Detailed Description

Colonoscopy is widely used for the investigation of lower gastrointestinal tract disease.However,colonoscopy remains a technically difficult procedure. As the colon is a mobile organ, looping may occur when the colonoscope passes through.Hence,reducing looping during procedure is very improtant to achieve succes as well as patient acceptance.Recently,some studies shown that cap-assisted colonoscopy(CAC)allow better visualisation of the colonic folds, thus increase success rate.However, previous studies shown that magnetic endoscope imaging (MEI)is useful as an adjunct to assist endoscopist in performing the procedure and as a modality to look for the mechanism of looping. Because of such concern,our study is to compare the mechanism of looping formation and acceptance of CAC and regular colonoscopy by MEI.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Hong Kong, China
    - Endoscopy Centre,Alice Ho Miu Ling Nethersole Hospital & Tai Po Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient undergo first colonoscopy examination
Signed informed consent

Exclusion Criteria:

Patient had received colonoscopy examination before.
Patient had prior colorectal surgery done(apart from appendectomy)
Known to have colonic stricture or obstructing tumour from the result of other investigations such as CT scan or barium enema.
Presence of acute surgical conditions such as severe colitis, megacolon, ischaemic colitis and active gastrointestinal bleeding.
Patient could not provide consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The MEI score difference between regular colonoscopy and CAC.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

Principal Investigator: Yuk Tong Lee, MD, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Registration Dates

First Submitted

August 16, 2006

First Submitted That Met QC Criteria

August 16, 2006

First Posted (Estimate)

August 17, 2006

Study Record Updates

Last Update Posted (Estimate)

March 26, 2010

Last Update Submitted That Met QC Criteria

March 25, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

First colonoscopy examination

Other Study ID Numbers

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.