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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00930462
Enrollment
400
Registered
2009-06-30
Start date
2008-03-31
Completion date
2009-02-28
Last updated
2009-06-30

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

Conditions

Colonoscopy

Keywords

colonoscopy, cap, hood, cecal intubation time, polyp detection rate, performance

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.

Interventions

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

Plastic cap fitted on the colonoscope

Sponsors

Royal Prince Alfred Hospital, Sydney, Australia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Time to cecumOne month

Secondary

MeasureTime frame
Polyp detection rateOne month

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026