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

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00153647
First received: September 8, 2005
Last updated: March 14, 2008
Last verified: August 2007
History of Changes
  Purpose

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.


Condition Intervention
Colonoscopy
Lower Gastrointestinal Tract
 Procedure: Cap-assisted colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Assess the Success Rate of Cap-Assisted Colonoscopy Versus Regular Colonoscopy for the First or Repeated Colonoscopy (CAC Study)

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • The success rate of cecal intubation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The procedure time to achieve cecal intubation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Success rate in achieving terminal ileum intubation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The procedure time to achieve terminal ileum intubation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Complications related to the procedure [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • The procedure difficulty as assessed by the endoscopist using a 10 cm visual analog scale [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The procedure difficulty of polypectomy if indicated as assessed by the endoscopist using a 10 cm visual analog scale [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The patient's pain score as assessed by the patient using a visual analog scale right after he regains full consciousness, which is assessed by accurately performing a deduction test (100 minus 7 test, correct for three deductions), before discharge [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The dose of the intravenous drugs used [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 1000
Study Start Date: May 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Cap-assisted Colonoscopy
 Procedure: Cap-assisted colonoscopy
Cap-assisted colonoscopy
Placebo Comparator: 2
Regular Colonoscopy
 Procedure: Cap-assisted colonoscopy
Cap-assisted colonoscopy

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153647

Locations
China
Endoscopy Center, Prince of Wales Hospital
Hong Kong, China
Endoscopy Center, Alice Ho Miu Ling Nethersole Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Y T Lee, MD Department of Medicine & Therapeutics, Prince of Wales Hospital
  More Information

No publications provided

Responsible Party: Francis K CHAN, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00153647     History of Changes
Other Study ID Numbers: CAC Study
Study First Received: September 8, 2005
Last Updated: March 14, 2008
Health Authority: Hong Kong: Department of Health

ClinicalTrials.gov processed this record on May 21, 2013