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A Comparison of an Ultra-thin and Standard Colonoscope in Achieving Caecal Intubation

NCT ID: NCT01142167

Last Updated: 2013-07-31

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

PHASE3

Total Enrollment

1121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-01-31

Brief Summary

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The aim of the study is to study the caecal intubation rate of a prototype ultra-thin colonoscope compared to a standard colonoscope and to study usefulness of this new colonoscope as a rescue instrument for failed initial colonoscopy with a standard colonoscope and to study the patient satisfaction scores using a validated endoscopy GHAA-9 for a new prototype colonoscope as compared to a standard colonoscope.

Detailed Description

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Colonoscopy is a common endoscopic procedure, widely used for the investigation of lower gastrointestinal tract diseases manifesting as altered bowel habit, per rectal bleeding and abdominal pain. It is used to diagnose colonic polyps, colorectal cancer and inflammatory bowel disease to name a few examples.

Colorectal cancer screening has been shown to decrease colorectal cancer. Despite this the uptake by the general population is suboptimal.

A new prototype colonoscope from Olympus with an additional distal bending section was designed. The investigators hypothesize that its performance characteristics will be similar to a standard colonoscope with patient tolerability.

This randomised control trial aims to invite patients attending their first outpatient colonoscopy and who are able to provide informed consent.(so they have had no prior experience) to assess the completion rate, patient and endoscopist satisfaction.

Patients with prior colorectal surgery or previous colonoscopy were excluded.

Conditions

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First Colonoscopy Examination

Keywords

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Ultra-thin colonoscope

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard Colonoscopy

Colonoscopy with standard instrument

Group Type ACTIVE_COMPARATOR

Standard Colonoscopy

Intervention Type PROCEDURE

Standard colonoscopy will be used during colonoscopy

Ultra-thin colonoscopy

New prototype scope

Group Type EXPERIMENTAL

Ultra-thin colonoscopy

Intervention Type PROCEDURE

Ultra-thin colonoscope will be used during colonoscopy

Interventions

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Standard Colonoscopy

Standard colonoscopy will be used during colonoscopy

Intervention Type PROCEDURE

Ultra-thin colonoscopy

Ultra-thin colonoscope will be used during colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* First outpatient colonoscopy
* Able to provide informed consent

Exclusion Criteria

* Unable to provide consent
* Prior colon surgery (except appendectomy)
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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James Yun-wong Lau

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Y Lau

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Endoscopy Center, Prince of Wales Hospital

Hong Kong, Hong Kong, China

Site Status

Countries

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China

References

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Luo DJ, Hui AJ, Yan KK, Ng SC, Wong VW, Chan FK, Cheong JP, Lam PP, Tse YK, Lau JY. A randomized comparison of ultrathin and standard colonoscope in cecal intubation rate and patient tolerance. Gastrointest Endosc. 2012 Mar;75(3):484-90. doi: 10.1016/j.gie.2011.07.032. Epub 2011 Oct 1.

Reference Type DERIVED
PMID: 21963069 (View on PubMed)

Other Identifiers

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UTC Study

Identifier Type: -

Identifier Source: org_study_id