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A Study to Assess Cap-Assisted Colonoscopy Versus Regular Colonoscopy for the First or Repeated Colonoscopy

NCT ID: NCT00153647

Last Updated: 2008-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-11-30

Brief Summary

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The primary aim of the study is to increase the success rate of cecal intubation in first colonoscopy and in repeated colonoscopy for the first failed procedure. The secondary aims are to assess the procedure time, the terminal ileum intubation rate, the endoscopist satisfaction score, the patients' acceptance, the complication rate of these two procedures, and the intravenous sedative drugs used.

Detailed Description

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Currently there is no consensus in how to improve the success rate of colonoscopy procedure given the fact that 10% of the procedures may fail. It has been suggested that using variable stiffness colonoscope (a colonoscope with a shaft that the stiffness can be altered), or even more sophisticated magnetic imaging colonoscopy (colonoscopy performed under a magnetic position detection sensor), could improve the success rate. However, these kinds of equipment are either expensive or not always available in the daily clinical practice. From some recent studies it was shown that adding a transparent cap to the tip of the colonoscope may improve the procedure success rate without increasing the complication rate of the procedure. The cost of the cap is cheap and it is available in almost every endoscopy center. Therefore the cap-assisted colonoscopy method may be an alternative which may improve the success rate of colonoscopy procedure, and reduce the pain and discomfort related to the procedure.

Conditions

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Colonoscopy Lower Gastrointestinal Tract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Cap-assisted Colonoscopy

Group Type ACTIVE_COMPARATOR

Cap-assisted colonoscopy

Intervention Type PROCEDURE

Cap-assisted colonoscopy

2

Regular Colonoscopy

Group Type PLACEBO_COMPARATOR

Cap-assisted colonoscopy

Intervention Type PROCEDURE

Cap-assisted colonoscopy

Interventions

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Cap-assisted colonoscopy

Cap-assisted colonoscopy

Intervention Type PROCEDURE

Cap-assisted colonoscopy

Cap-assisted colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who undergo their first colonoscopy examination

Exclusion Criteria

* Patients had received colonoscopy examination before
* Patients had prior colorectal surgery done (apart from appendectomy)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Chinese University of Hong Kong

Principal Investigators

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Y T Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine & Therapeutics, Prince of Wales Hospital

Locations

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Endoscopy Center, Alice Ho Miu Ling Nethersole Hospital

Hong Kong, , China

Site Status

Endoscopy Center, Prince of Wales Hospital

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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CAC Study

Identifier Type: -

Identifier Source: org_study_id