Colon Neoplasms
Conditions
Keywords
colonoscopy, adenoma detection rate, full spectrum colonoscopy, right colon retroflexion, feasibility
Brief summary
The aim of this study is to evaluate FUSE-colonoscopy in terms of feasibility and its possible additive contribution in the detection of important lesions, namely polyps and cancers, compared to the standard forward-viewing approach, with and without the addition of the right-colon retroflexion technique, in a series of patients undergoing back-to-back screening or surveillance colonoscopies in a randomized fashion.
Detailed description
We changed the anticipated number of subjects enrollment for study: NCT02117674 from 120 to 200 based on the following sample size estimation: Tandem colonoscopies studies results, show that novel endoscopic technologies detect about 20% more adenomas than those conventional colonoscopy does (missed adenomas). Since FUSE colonoscopy cannot be considered as a perfect examination, we hypothesize that conventional colonoscopy will detect one third of the missed adenomas that FUSE 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 FUSE 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 forward-viewing colonoscopy
examination of the colon with a conventional colonoscope
PROCEDUREfull-spectrum colonoscopy
examination of the colon with full-spectrum colonoscope
PROCEDUREright colon retroflexion
examination of the right colon with scope retroflexion (both with conventional and fuse scope)
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 over 80 years * poor overall health (ASA III, IV) * recent abdominal surgery * presence of abdominal wall hernias * active colitis * multiple right colon diverticula * previous bowel resection * inflammatory bowel disease * polyposis syndromes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| polyp detection rate | one week | per colon segment and for the entire colon |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| colonoscopy completion | one week | colonoscopy completion rate |
| procedure time | one week | intubation and withdrawal time |
| adverse events | one week | adverse events rate |
| patients' satisfaction | one week | patients' satisfaction, quantified using a scale from 0 (not satisfied at all) to 10 (completely satisfied) |
| feasibility of the retroflexion in the right colon by trainee | one week | feasibility of retroflexion in the right colon by trainee, meaning if the trainee managed to perform the right colon retroflexion or not |
| feasibility of retroflexion in the right colon by the consultant | one week | feasibility of retroflexion in the right colon by the consultant, meaning if the consultant managed to perform the right colon retroflexion or not |
| endoscopist's satisfaction | one week | endoscopist's satisfaction quantified using a scale from 0 (not satisfied) to 10 (completely satisfied) |
Countries
Greece
Outcome results
None listed