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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00153647
Other study ID # CAC Study
Secondary ID
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


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
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