Clinical trial NCT01142167: A Comparison of an Ultra-thin and Standard Colonoscope in Achieving Caecal Intubation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: First Colonoscopy Examination
Keywords: Ultra-thin colonoscope
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-06-11
Enrollment: 1121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* First outpatient colonoscopy
* Able to provide informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Successful Caecal intubation
timeFrame: 12 weeks
Secondary outcomes:
measure: Caecal intubation time
timeFrame: 12 weeks
measure: Patient Satisfaction and Pain score
timeFrame: 12 weeks
measure: Endoscopist satisfaction
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Endoscopy Center, Prince of Wales Hospital
state: Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: James Y Lau
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luo DJ, Hui AJ, Yan KK, Ng SC, Wong VW, Chan FK, Cheong JP, Lam PP, Tse YK, Lau JY. A randomized comparison of ultrathin and standard colonoscope in cecal intubation rate and patient tolerance. Gastrointest Endosc. 2012 Mar;75(3):484-90. doi: 10.1016/j.gie.2011.07.032. Epub 2011 Oct 1.