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

Phase 3

Completed

• Conditions: First Colonoscopy Examination
• Interventions: Procedure: Standard Colonoscopy; Procedure: Ultra-thin colonoscopy

• Registration Number: NCT01142167
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1121

Inclusion Criteria

• First outpatient colonoscopy
• Able to provide informed consent

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Exclusion Criteria

• Unable to provide consent
• Prior colon surgery (except appendectomy)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard Colonoscopy	Standard Colonoscopy	Colonoscopy with standard instrument
Ultra-thin colonoscopy	Ultra-thin colonoscopy	New prototype scope

Primary Outcome Measures

Name	Time	Method
Successful Caecal intubation	12 weeks	Success of Caecal intubation for the ultra-thin colonoscope vs standard colonoscope

Secondary Outcome Measures

Name	Time	Method
Caecal intubation time	12 weeks	Caecal intubation time Ultra-thin colonsocope vs standard colonoscope
Patient Satisfaction and Pain score	12 weeks	Patient tolerability Ultra-thin vs standard colonoscope
Endoscopist satisfaction	12 weeks	Ease of use prototype scope vs standard colonoscope

Trial Locations

Locations (1)

Endoscopy Center, Prince of Wales Hospital; 🇨🇳 Hong Kong, Hong Kong, China