Clinical trial NCT02340065: Endocuff-assisted vs. Standard Colonoscopy
Official title: Endocuff-assisted vs. Standard Colonoscopy: a Randomized, Back-to-Back Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Neoplasms
Keywords: colonoscopy
adenoma detection rate
Endocuff-assisted colonoscopy
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2015-01-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: number and rate of missed adenomas
timeFrame: one week
Secondary outcomes:
measure: number of adenomas and adenoma detection rate in the entire colon
timeFrame: one week
measure: number of adenomas and adenoma detection rate in the right colon
timeFrame: one week
measure: number of polyps and polyp detection rate in the entire colon
timeFrame: one week
measure: number of polyps and polyp detection rate in the right colon
timeFrame: one week
measure: colonoscopy completion (colonoscopy completion rate, reason for incomplete colonoscopy)
timeFrame: one week
measure: intubation and withdrawal time
timeFrame: one week
measure: adverse events
timeFrame: one week
measure: endoscopist's satisfaction (quantified using a scale from 0 (not satisfied) to 10 (completely satisfied)
timeFrame: one week
measure: mean number of adenomas per procedure
timeFrame: one week
Other outcomes:
Locations:
city: Haidari
country: Greece
facility: Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital
state: Attica
Study officials:
affiliation: Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece
name: KONSTANTINOS TRIANTAFYLLOU, PROF
role: STUDY_CHAIR
affiliation: Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece
name: DIMITRIOS POLYMEROS, MD
role: STUDY_DIRECTOR
References:
citation: Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.
citation: Biecker E, Floer M, Heinecke A, Strobel P, Bohme R, Schepke M, Meister T. Novel endocuff-assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled trial. J Clin Gastroenterol. 2015 May-Jun;49(5):413-8. doi: 10.1097/MCG.0000000000000166.
citation: Triantafyllou K, Polymeros D, Apostolopoulos P, Lopes Brandao C, Gkolfakis P, Repici A, Papanikolaou IS, Dinis-Ribeiro M, Alexandrakis G, Hassan C. Endocuff-assisted colonoscopy is associated with a lower adenoma miss rate: a multicenter randomized tandem study. Endoscopy. 2017 Nov;49(11):1051-1060. doi: 10.1055/s-0043-114412. Epub 2017 Aug 1.