Colonoscopy, Lower Gastrointestinal Tract
Conditions
Keywords
colonoscopy, Lower Gastrointestinal Tract, Cecal intubation, Cap-attached colonoscopy, Trainee
Brief summary
The aim of this prospective randomized controlled trial is to assess the efficacy of cap-attached colonoscopy to improve cecal intubation in comparison with regular colonoscopy for trainees.
Detailed description
Colorectal cancer is one of the major malignancies in western countries and also in Japan. Therefore , the demand for total colonoscopy (TCS) has risen remarkably. However, failure to reach the cecum occurs in up to 10 % of cases. A difficult colonoscopy procedure will often be associated with more complications, and require heavier sedation to alleviate patient's discomfort. Auxiliary devices that could facilitate the examination would be needed. A cap is a simple device that can be attached to the tip of a colonoscope. The advantage of the cap in getting a good view might be helpful in cecal intubation by depressing the folds and also by keeping an appropriate distance between the colonoscope lens and colonic mucosa. We speculated that inexperienced colonoscopists would obtain greater benefit from cap-attached colonoscopy.
Interventions
DEVICECap-attached Colonoscopy Versus Regular Colonoscopy
Trainees were divided into two group; Cap-attached Colonoscopy group or Regular Colonoscopy group. Trainees allocated to the former group undergo colonoscopy with cap for all cases, the latter without cap.
Sponsors
Showa University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who undergo colonoscopy examination
Exclusion criteria
* 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 ・Patients who diagnosed as inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of cecal intubation | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Success rate in achieving terminal ileum intubation | 24 hours |
| The procedure time to achieve terminal ileum intubation | 24 hours |
| The procedure time to achieve cecal intubation | 24 hours |
| The dose of the intravenous drugs used | 24 hours |
| The polyp detection rate | 24 hours |
| Complications related to the procedure | 24 hours |
Countries
Japan
Outcome results
None listed