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Completed

NCT Number: NCT00930462

Evaluation of the Use of Cap in Improving the Performance of Colonoscopy

The aim of this study is to compare the colonoscopy success rate, cecal time and polyp detection rate between cap-fitted colonoscopy and conventional colonoscopy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

About this study

Colonoscopic examination has been used in clinical practice for approximately 40 years. Despite the fact that colonoscopy is widely available and is performed by many experienced colonoscopists there are concerns about the quality of colonoscopy as measured by several technical endpoints such as rate of failed caecal intubation and polyp miss rate. A large population-based study revealed 13.1% of colonoscopies failed to reach the cecum. In addition, one large review of back-to-back colonoscopies showed polyp miss rates of 24% for adenoma.

One potentially promising technique is cap-assisted colonoscopy. A transparent cap (or "hood") is a simple plastic device that can be attached to the tip of a colonoscope before performing the colonoscopy. Several randomized trials from Japan have mixed results regarding improved cecal intubation times and polyp detection rates. A recent large study from Hong Kong showed improved time to cecum but a reduced polyp detection rate. To date there is no large randomized study using the cap in a western population, in whom the colorectal cancer (CRC) incidence is known to be higher. We plan to conduct a randomized controlled trial to investigate the usefulness of cap-assisted colonoscopy in a Western population.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All colonoscopy patients referred for colonoscopy at Royal Prince Alfred Hospital.

Exclusion criteria

  • Prior colonic resection
  • Pregnancy.
  • Severe co-morbidities.
  • Tertiary referral for endo-mucosal resection.
  • Acute surgical conditions such as severe colitis, toxic megacolon, ischemic colitis, acute gastrointestinal bleeding.

Treatment and study plan

Cap (Olympus Medical Systems: D-201-15004, D-201-14304 and D-201-12704)

Device

Plastic cap fitted on the colonoscope

Other names: D-201-15004, D-201-14304 and D-201-12704, Olympus Medical Systems, Tokyo, Japan.

Primary outcomes

  1. Time to cecum

    Time frame: One month

Secondary outcomes

  1. Polyp detection rate

    Time frame: One month

Sponsors and collaborators

Lead sponsor

Royal Prince Alfred Hospital, Sydney, Australia

Other

Registry information

Official study title

A Prospective Randomised Controlled Trial Comparing Cap-Assisted Colonoscopy Versus Standard Colonoscopy

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 30, 2009
Registry last updated
Jun 30, 2009

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.

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