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

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).

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01142167
Enrollment
1121
Registered
2010-06-11
Start date
2009-10-31
Completion date
2011-01-31
Last updated
2013-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First Colonoscopy Examination

Keywords

Ultra-thin colonoscope

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.

Interventions

PROCEDUREStandard Colonoscopy

Standard colonoscopy will be used during colonoscopy

PROCEDUREUltra-thin colonoscopy

Ultra-thin colonoscope will be used during colonoscopy

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* First outpatient colonoscopy * Able to provide informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Successful Caecal intubation12 weeksSuccess of Caecal intubation for the ultra-thin colonoscope vs standard colonoscope

Secondary

MeasureTime frameDescription
Caecal intubation time12 weeksCaecal intubation time Ultra-thin colonsocope vs standard colonoscope
Patient Satisfaction and Pain score12 weeksPatient tolerability Ultra-thin vs standard colonoscope
Endoscopist satisfaction12 weeksEase of use prototype scope vs standard colonoscope

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026