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

R

Royal Prince Alfred Hospital

Status and phase

Completed
Phase 4

Conditions

Colonoscopy

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00930462
CAPCOLON
X07-0107

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

400 participants in 2 patient groups

Conventional colonoscopy
No Intervention group
Description:
No cap fitted on the colonoscopes for this group.
Cap-assisted colonoscopy
Experimental group
Treatment:
Device: Cap (Olympus Medical Systems: D-201-15004, D-201-14304 and D-201-12704)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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