A Comparison of an Ultra-thin and Standard Colonoscope in Achieving Caecal Intubation
|First Colonoscopy Examination||Procedure: Standard Colonoscopy Procedure: Ultra-thin colonoscopy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (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).|
- 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
|Study Start Date:||October 2009|
|Study Completion Date:||January 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|