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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01142167
First received: June 9, 2010
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
First Colonoscopy Examination
Procedure: Standard Colonoscopy
Procedure: Ultra-thin colonoscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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).

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Successful Caecal intubation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Success of Caecal intubation for the ultra-thin colonoscope vs standard colonoscope


Secondary Outcome Measures:
  • Caecal intubation time [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Caecal intubation time Ultra-thin colonsocope vs standard colonoscope

  • Patient Satisfaction and Pain score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Patient tolerability Ultra-thin vs standard colonoscope

  • Endoscopist satisfaction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Ease of use prototype scope vs standard colonoscope


Enrollment: 1121
Study Start Date: October 2009
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First outpatient colonoscopy
  • Able to provide informed consent

Exclusion Criteria:

  • Unable to provide consent
  • Prior colon surgery (except appendectomy)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142167

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

No publications provided by Chinese University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01142167     History of Changes
Other Study ID Numbers: UTC Study
Study First Received: June 9, 2010
Last Updated: July 29, 2013
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Ultra-thin colonoscope

ClinicalTrials.gov processed this record on April 16, 2014