The primary aim of the study is to increase the success rate of caecal 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, patients’ acceptance, complication rate of these two procedures and the intravenous sedative drugs used.

Condition	Intervention
Lower Gastrointestinal Tract	Procedure: Cap-assisted colonoscopy

Further Study Details: 

Primary Outcomes: The success rate of cecal intubation.
Secondary Outcomes: The procedure time to achieve caecal intubation.; Success rate in achieving terminal ileum intubation.; The procedure time to achieve terminal ileum intubation.; Complications related to the procedure; The procedure difficulty as assessed by the endoscopist; using a 10cm visual analog scale; The procedure difficulty of polypectomy if indicated as; assessed by the endoscopist using a 10cm visual analog; scale; 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.; The dose of the intravenous drugs used.
Expected Total Enrollment:  948

Currently there is no consensus in how to improve the success rate of colonoscopy procedure giving the fact that 10% of the procedure may be failed. 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 (1). From some recent studies, it was shown that by adding a transparent cap to the tip of the colonoscope, it may improve the procedure success rate but without increasing the complication rate of the procedure (2, 3). 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 to improve the success rate of colonoscopy procedure, and reduce the pain and discomfort related to the procedure.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients 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 tumour from the results of other investigations such as CT scan or barium enema.
• Presence of acute surgical conditions such as severe colitis, megacolon, ischaemic colitis and active gastrointestinal bleeding.

Please refer to this study by ClinicalTrials.gov identifier  NCT00153647

Y T Lee, MD      85226323131    leeytong@cuhk.edu.hk
Jessica Y Ching, MPH      85226323524    jessicaching@cuhk.edu.hk

China
      Endoscopy Center, Prince of Wales Hospital, Hong Kong,  China; Recruiting
      Endoscopy Center, Alice Ho Miu Ling Nethersole Hospital, Hong Kong,  China; Recruiting

Study chairs or principal investigators

Y T Lee, MD,  Principal Investigator,  Department of Medicine & Therapeutics, Prince of Wales Hospital   

Study ID Numbers:  CAC Study
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00153647
Health Authority: Hong Kong: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13