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Clinical Trials/NCT00930462
NCT00930462CompletedPhase 4

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

Royal Prince Alfred Hospital, Sydney, Australia1 site in 1 country400 target enrollmentStarted: March 1, 2008Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
400
Locations
1
Primary Endpoint
Time to cecum

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Time to cecum

Time Frame: One month

Secondary Outcomes

  • Polyp detection rate(One month)

Investigators

Sponsor
Royal Prince Alfred Hospital, Sydney, Australia
Sponsor Class
Other

Study Sites (1)

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