A Comparison of an Ultra-thin and Standard Colonoscope in Achieving Caecal Intubation
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|ClinicalTrials.gov Identifier: NCT01142167|
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : July 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|First Colonoscopy Examination||Procedure: Standard Colonoscopy Procedure: Ultra-thin colonoscopy||Phase 3|
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|
|Intervention Model:||Crossover Assignment|
|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|
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
- Successful Caecal intubation [ Time Frame: 12 weeks ]Success of Caecal intubation for the ultra-thin colonoscope vs standard colonoscope
- Caecal intubation time [ Time Frame: 12 weeks ]Caecal intubation time Ultra-thin colonsocope vs standard colonoscope
- Patient Satisfaction and Pain score [ Time Frame: 12 weeks ]Patient tolerability Ultra-thin vs standard colonoscope
- Endoscopist satisfaction [ Time Frame: 12 weeks ]Ease of use prototype scope vs standard colonoscope
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 ClinicalTrials.gov identifier (NCT number): NCT01142167
|China, Hong Kong|
|Endoscopy Center, Prince of Wales Hospital|
|Hong Kong, Hong Kong, China|
|Principal Investigator:||James Y Lau||Chinese University of Hong Kong|