Skip to main content
OpenTrials
Completed

NCT Number: NCT01142167

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

First Colonoscopy Examination

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Endoscopy Center, Prince of Wales Hospital

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First outpatient colonoscopy
  • Able to provide informed consent

Exclusion criteria

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

Treatment and study plan

Standard colonoscopy

Procedure

Standard colonoscopy will be used during colonoscopy

Ultra-thin colonoscopy

Procedure

Ultra-thin colonoscope will be used during colonoscopy

Primary outcomes

  1. Successful Caecal intubation

    Time frame: 12 weeks

    Success of Caecal intubation for the ultra-thin colonoscope vs standard colonoscope

Secondary outcomes

  1. Caecal intubation time

    Time frame: 12 weeks

    Caecal intubation time Ultra-thin colonsocope vs standard colonoscope

  2. Patient Satisfaction and Pain score

    Time frame: 12 weeks

    Patient tolerability Ultra-thin vs standard colonoscope

  3. Endoscopist satisfaction

    Time frame: 12 weeks

    Ease of use prototype scope vs standard colonoscope

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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).

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jun 11, 2010
Registry last updated
Jul 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.