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

Not Applicable

Completed

• Conditions: Lower Gastrointestinal Tract; Colonoscopy
• Interventions: Procedure: Cap-assisted colonoscopy

• Registration Number: NCT00153647
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2007-08
• Last Update Submitted: 2008-03-14
• Last Update Posted: 2008-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients who undergo their first colonoscopy examination

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Cap-assisted colonoscopy	Regular Colonoscopy
1	Cap-assisted colonoscopy	Cap-assisted Colonoscopy

Primary Outcome Measures

Name	Time	Method
The success rate of cecal intubation	24 hours

Secondary Outcome Measures

Name	Time	Method
Success rate in achieving terminal ileum intubation	24 hours
Complications related to the procedure	24 hours
The procedure time to achieve cecal intubation	24 hours
The procedure difficulty of polypectomy if indicated as assessed by the endoscopist using a 10 cm visual analog scale	24 hours
The procedure time to achieve terminal ileum intubation	24 hours
The procedure difficulty 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

Trial Locations

Locations (2)

Endoscopy Center, Prince of Wales Hospital; 🇨🇳 Hong Kong, China

Endoscopy Center, Alice Ho Miu Ling Nethersole Hospital; 🇨🇳 Hong Kong, China