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

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

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy; Lower Gastrointestinal Tract
• Intervention / Treatment: Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Endoscopy Center, Prince of Wales Hospital
  • Hong Kong, China
    • Endoscopy Center, Alice Ho Miu Ling Nethersole Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The success rate of cecal intubation	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
The procedure time to achieve cecal intubation	24 hours
Success rate in achieving terminal ileum intubation	24 hours
The procedure time to achieve terminal ileum intubation	24 hours
Complications related to the procedure	24 hours
The dose of the intravenous drugs used	24 hours
The procedure difficulty as assessed by the endoscopist using a 10 cm visual analog scale	24 hours
The procedure difficulty of polypectomy if indicated as assessed by the endoscopist using a 10 cm visual analog scale	24 hours
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	24 hours

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Y T Lee, MD, Department of Medicine & Therapeutics, Prince of Wales Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 8, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): March 18, 2008
• Last Update Submitted That Met QC Criteria: March 14, 2008
• Last Verified: August 1, 2007

More Information

Terms related to this study

• Other Study ID Numbers: CAC Study