Endocuff-assisted vs. Standard Colonoscopy

Overview

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.

Full Title of Study: “Endocuff-assisted vs. Standard Colonoscopy: a Randomized, Back-to-Back Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2016

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

  • Procedure: standard colonoscopy
    • examination of the colon with a conventional colonoscope
  • Procedure: Endocuff-assisted colonoscopy
    • examination of the colon with Endocuff-assisted colonoscopy

Arms, Groups and Cohorts

  • Active Comparator: standard colonoscopy
    • total polyp/adenoma detection with standard colonoscopy, polyp/adenoma detection in the right colon with standard colonoscopy
  • Active Comparator: Endocuff-assisted colonoscopy
    • total polyp/adenoma detection with Endocuff-assisted colonoscopy, polyp/adenoma detection in the right colon with Endocuff-assisted colonoscopy

Clinical Trial Outcome Measures

Primary Measures

  • number and rate of missed adenomas
    • Time Frame: one week
    • in the entire colon

Secondary Measures

  • number of adenomas and adenoma detection rate in the entire colon
    • Time Frame: one week
    • with both Endocuff-assisted and standard colonoscopy
  • number of adenomas and adenoma detection rate in the right colon
    • Time Frame: one week
    • with both Endocuff-assisted and standard colonoscopy
  • number of polyps and polyp detection rate in the entire colon
    • Time Frame: one week
    • with both Endocuff-assisted and standard colonoscopy
  • number of polyps and polyp detection rate in the right colon
    • Time Frame: one week
    • with both Endocuff-assisted and standard colonoscopy
  • colonoscopy completion (colonoscopy completion rate, reason for incomplete colonoscopy)
    • Time Frame: one week
    • colonoscopy completion rate, reason for incomplete colonoscopy
  • intubation and withdrawal time
    • Time Frame: one week
    • for both Endocuff-assisted and standard colonoscopy (time spent for therapeutic procedures is excluded)
  • adverse events
    • Time Frame: one week
    • adverse event rate
  • endoscopist’s satisfaction (quantified using a scale from 0 (not satisfied) to 10 (completely satisfied)
    • Time Frame: 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
    • Time Frame: one week
    • with both Endocuff-assisted and standard colonoscopy

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Attikon Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: ATHANASIOS SIOULAS, Dr – Attikon Hospital
  • Overall Official(s)
    • KONSTANTINOS TRIANTAFYLLOU, PROF, Study Chair, Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece
    • DIMITRIOS POLYMEROS, MD, Study Director, Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece

References

Floer M, Biecker E, Fitzlaff R, Röming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Ströbel 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.

Biecker E, Floer M, Heinecke A, Ströbel P, Böhme 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.

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