Clinical trial NCT00153647: A Study to Assess Cap-Assisted Colonoscopy Versus Regular Colonoscopy for the First or Repeated Colonoscopy
Official title: A Study to Assess the Success Rate of Cap-Assisted Colonoscopy Versus Regular Colonoscopy for the First or Repeated Colonoscopy (CAC Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Lower Gastrointestinal Tract
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The success rate of cecal intubation
timeFrame: 24 hours
Secondary outcomes:
measure: The procedure time to achieve cecal intubation
timeFrame: 24 hours
measure: Success rate in achieving terminal ileum intubation
timeFrame: 24 hours
measure: The procedure time to achieve terminal ileum intubation
timeFrame: 24 hours
measure: Complications related to the procedure
timeFrame: 24 hours
measure: The procedure difficulty as assessed by the endoscopist using a 10 cm visual analog scale
timeFrame: 24 hours
measure: The procedure difficulty of polypectomy if indicated as assessed by the endoscopist using a 10 cm visual analog scale
timeFrame: 24 hours
measure: 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
timeFrame: 24 hours
measure: The dose of the intravenous drugs used
timeFrame: 24 hours
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Endoscopy Center, Alice Ho Miu Ling Nethersole Hospital
city: Hong Kong
country: China
facility: Endoscopy Center, Prince of Wales Hospital
Study officials:
affiliation: Department of Medicine & Therapeutics, Prince of Wales Hospital
name: Y T Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: