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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Colonoscopy, Lower Gastrointestinal Tract

Intervention / Treatment
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* Procedure: Cap-assisted colonoscopy
* Procedure: Cap-assisted colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Cap-assisted Colonoscopy | Procedure: Cap-assisted colonoscopy<br>* Cap-assisted colonoscopy<br>|
| Placebo Comparator: 2<br>Regular Colonoscopy | Procedure: Cap-assisted colonoscopy<br>* Cap-assisted colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 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 | 
| The dose of the intravenous drugs used |  | 24 hours |