Colonoscopy Clinical Trial
— CACOfficial title:
A Study to Assess the Success Rate of Cap-Assisted Colonoscopy Versus Regular Colonoscopy for the First or Repeated Colonoscopy (CAC Study)
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Endoscopy Center, Alice Ho Miu Ling Nethersole Hospital | Hong Kong | |
China | Endoscopy Center, Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
China,
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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