A Study to Assess Cap-Assisted Colonoscopy Versus Regular Colonoscopy for the First or Repeated Colonoscopy (CAC)

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Completed

Conditions

Lower Gastrointestinal Tract
Colonoscopy

Treatments

Procedure: Cap-assisted colonoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT00153647
CAC Study

Details and patient eligibility

About

The primary aim of the study is to increase the success rate of cecal intubation in first colonoscopy and in repeated colonoscopy for the first failed procedure. The secondary aims are to assess the procedure time, the terminal ileum intubation rate, the endoscopist satisfaction score, the patients' acceptance, the complication rate of these two procedures, and the intravenous sedative drugs used.

Full description

Currently there is no consensus in how to improve the success rate of colonoscopy procedure given the fact that 10% of the procedures may fail. It has been suggested that using variable stiffness colonoscope (a colonoscope with a shaft that the stiffness can be altered), or even more sophisticated magnetic imaging colonoscopy (colonoscopy performed under a magnetic position detection sensor), could improve the success rate. However, these kinds of equipment are either expensive or not always available in the daily clinical practice. From some recent studies it was shown that adding a transparent cap to the tip of the colonoscope may improve the procedure success rate without increasing the complication rate of the procedure. The cost of the cap is cheap and it is available in almost every endoscopy center. Therefore the cap-assisted colonoscopy method may be an alternative which may improve the success rate of colonoscopy procedure, and reduce the pain and discomfort related to the procedure.

Enrollment

1,000 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who undergo their first colonoscopy examination

Exclusion criteria

  • Patients had received colonoscopy examination before
  • Patients had prior colorectal surgery done (apart from appendectomy)
  • Known to have colonic stricture or obstructing tumor from the results of other investigations such as CT scan or barium enema
  • Presence of acute surgical conditions such as severe colitis, megacolon, ischemic colitis and active gastrointestinal bleeding

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,000 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Description:
Cap-assisted Colonoscopy
Treatment:
Procedure: Cap-assisted colonoscopy
2
Placebo Comparator group
Description:
Regular Colonoscopy
Treatment:
Procedure: Cap-assisted colonoscopy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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