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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01142167
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : July 31, 2013
Information provided by (Responsible Party):
James Yun-wong Lau, 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.

Condition or disease Intervention/treatment Phase
First Colonoscopy Examination Procedure: Standard Colonoscopy Procedure: Ultra-thin colonoscopy Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 1121 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: A Study to Assess the Success Rate of Ultra-thin Colonoscopy Versus Conventional Colonoscopy for the First or Rescue Colonoscopy for Unsuccessful Procedures (UTC Study).
Study Start Date : October 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Active Comparator: Standard Colonoscopy
Colonoscopy with standard instrument
Procedure: Standard Colonoscopy
Standard colonoscopy will be used during colonoscopy

Experimental: Ultra-thin colonoscopy
New prototype scope
Procedure: Ultra-thin colonoscopy
Ultra-thin colonoscope will be used during colonoscopy

Primary Outcome Measures :
  1. Successful Caecal intubation [ Time Frame: 12 weeks ]
    Success of Caecal intubation for the ultra-thin colonoscope vs standard colonoscope

Secondary Outcome Measures :
  1. Caecal intubation time [ Time Frame: 12 weeks ]
    Caecal intubation time Ultra-thin colonsocope vs standard colonoscope

  2. Patient Satisfaction and Pain score [ Time Frame: 12 weeks ]
    Patient tolerability Ultra-thin vs standard colonoscope

  3. Endoscopist satisfaction [ Time Frame: 12 weeks ]
    Ease of use prototype scope vs standard colonoscope

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • First outpatient colonoscopy
  • Able to provide informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01142167

China, Hong Kong
Endoscopy Center, Prince of Wales Hospital
Hong Kong, Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: James Y Lau Chinese University of Hong Kong

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong Identifier: NCT01142167     History of Changes
Other Study ID Numbers: UTC Study
First Posted: June 11, 2010    Key Record Dates
Last Update Posted: July 31, 2013
Last Verified: July 2013

Keywords provided by James Yun-wong Lau, Chinese University of Hong Kong:
Ultra-thin colonoscope