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

Colonoscopy Clinical Trial

— CAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153647
• Other study ID #: CAC Study
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: March 14, 2008
• Start date: May 2005
• Est. completion date: November 2006

Study information

• Verified date: August 2007
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy
• Lower Gastrointestinal Tract

Intervention

Procedure:
• Cap-assisted colonoscopy
Cap-assisted colonoscopy
• Cap-assisted colonoscopy
Cap-assisted colonoscopy

Locations

Country	Name	City	State
China	Endoscopy Center, Alice Ho Miu Ling Nethersole Hospital	Hong Kong
China	Endoscopy Center, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of cecal intubation		24 hours	No
Secondary	The procedure time to achieve cecal intubation		24 hours	No
Secondary	Success rate in achieving terminal ileum intubation		24 hours	No
Secondary	The procedure time to achieve terminal ileum intubation		24 hours	No
Secondary	Complications related to the procedure		24 hours	Yes
Secondary	The procedure difficulty as assessed by the endoscopist using a 10 cm visual analog scale		24 hours	No
Secondary	The procedure difficulty of polypectomy if indicated as assessed by the endoscopist using a 10 cm visual analog scale		24 hours	No
Secondary	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	No
Secondary	The dose of the intravenous drugs used		24 hours	No