Colon Neoplasms
Conditions
Keywords
colonoscopy, adenoma detection rate, Endocuff-assisted colonoscopy
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.
Interventions
PROCEDUREstandard colonoscopy
examination of the colon with a conventional colonoscope
PROCEDUREEndocuff-assisted colonoscopy
examination of the colon with Endocuff-assisted colonoscopy
Sponsors
Attikon Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* adults undergoing elective screening or surveillance colonoscopy * symptomatic adults with indication for colonoscopy
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number and rate of missed adenomas | one week | in the entire colon |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| number of polyps and polyp detection rate in the right 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 |
| number of adenomas and adenoma detection rate in the entire colon | one week | with both Endocuff-assisted and standard colonoscopy |
| adverse events | one week | adverse event rate |
| 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 |
| mean number of adenomas per procedure | one week | with both Endocuff-assisted and standard colonoscopy |
| intubation and withdrawal time | one week | for both Endocuff-assisted and standard colonoscopy (time spent for therapeutic procedures is excluded) |
Countries
Greece
Outcome results
None listed