Endocuff-assisted vs. Standard Colonoscopy
- Conditions
- Colon Neoplasms
- Interventions
- Procedure: Endocuff-assisted colonoscopyProcedure: standard colonoscopy
- Registration Number
- NCT02340065
- Lead Sponsor
- Attikon Hospital
- Brief Summary
The aim of this study is to evaluate Endocuff- assisted colonoscopy in terms of its possible additive contribution in the detection of important lesions, namely polyps and cancers, compared to standard colonoscopy, in a series of patients undergoing back-to-back screening or surveillance colonoscopies in a randomized fashion. Moreover, we aim to assess possible changes regarding post-polypectomy surveillance programs following Endocuff utilization.
- Detailed Description
Tandem colonoscopies studies results, show that novel endoscopic technologies detect about 20% more adenomas than those conventional colonoscopy does (missed adenomas). Since Endocuff-assisted colonoscopy cannot be considered as a perfect examination, we hypothesize that conventional colonoscopy will detect one third of the missed adenomas that Endocuff-assisted colonoscopy detects in a similar setting. Therefore a sample size of 120 adenomas achieves 80% power to detect an odds ratio of 3.0 using a two-sided McNemar test with a significance level of 0.05. The odds ratio is equivalent to a difference between two paired proportions of 14% which occurs when the proportion of detected missed adenomas during Endocuff-assisted colonoscopy is 21% and the proportion of missed adenomas during conventional colonoscopy is 7%. During one year period before the study initiation, our colonoscopy performance quality data show that we detect a mean number of adenomas per patient equal of 0.7 in a population similar to the one recruited in our study. Therefore, 172 patients overall will be required to detect 120 adenomas. Given the uncertainty of our estimation and in order to cope with patients exclusions, withdrawals and unexpected incomplete colonoscopies, we decided to recruit 200 patients.
A more extensive description regarding the investigators study is provided in the following fields.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- adults undergoing elective screening or surveillance colonoscopy
- symptomatic adults with indication for colonoscopy
- age<18 and > 80 years
- poor overall health (ASA III, IV)
- recent abdominal surgery
- presence of abdominal wall hernias
- active colitis
- previous bowel resection
- inflammatory bowel disease
- polyposis syndromes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description standard colonoscopy Endocuff-assisted colonoscopy total polyp/adenoma detection with standard colonoscopy, polyp/adenoma detection in the right colon with standard colonoscopy Endocuff-assisted colonoscopy standard colonoscopy total polyp/adenoma detection with Endocuff-assisted colonoscopy, polyp/adenoma detection in the right colon with Endocuff-assisted colonoscopy
- Primary Outcome Measures
Name Time Method number and rate of missed adenomas one week in the entire colon
- Secondary Outcome Measures
Name Time Method number of adenomas and adenoma detection rate in the entire colon one week with both Endocuff-assisted and standard colonoscopy
mean number of adenomas per procedure one week with both Endocuff-assisted and standard colonoscopy
number of polyps and polyp detection rate in the right colon one week with both Endocuff-assisted and standard colonoscopy
endoscopist's satisfaction (quantified using a scale from 0 (not satisfied) to 10 (completely satisfied) one week endoscopist's satisfaction quantified using a scale from 0 (not satisfied) to 10 (completely satisfied) for Endocuff-assisted colonoscopy
number of adenomas and adenoma detection rate in the right colon one week with both Endocuff-assisted and standard colonoscopy
number of polyps and polyp detection rate in the entire colon one week with both Endocuff-assisted and standard colonoscopy
colonoscopy completion (colonoscopy completion rate, reason for incomplete colonoscopy) one week colonoscopy completion rate, reason for incomplete colonoscopy
intubation and withdrawal time one week for both Endocuff-assisted and standard colonoscopy (time spent for therapeutic procedures is excluded)
adverse events one week adverse event rate
Trial Locations
- Locations (1)
Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital
🇬🇷Haidari, Attica, Greece