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).
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,121
- Locations
- 1
- Primary Endpoint
- Successful Caecal intubation
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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)
Outcomes
Primary Outcomes
Successful Caecal intubation
Time Frame: 12 weeks
Success of Caecal intubation for the ultra-thin colonoscope vs standard colonoscope
Secondary Outcomes
- Caecal intubation time(12 weeks)
- Patient Satisfaction and Pain score(12 weeks)
- Endoscopist satisfaction(12 weeks)
Investigators
James Yun-wong Lau
Professor
Chinese University of Hong Kong