Endocuff-assisted vs. Standard Colonoscopy

NCT ID: NCT02340065

Last Updated: 2016-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-04-30

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.

Conditions

Colon Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

standard colonoscopy

total polyp/adenoma detection with standard colonoscopy, polyp/adenoma detection in the right colon with standard colonoscopy

Group Type: ACTIVE_COMPARATOR

Endocuff-assisted colonoscopy

Intervention Type: PROCEDURE

examination of the colon with Endocuff-assisted colonoscopy

Endocuff-assisted colonoscopy

total polyp/adenoma detection with Endocuff-assisted colonoscopy, polyp/adenoma detection in the right colon with Endocuff-assisted colonoscopy

Group Type: ACTIVE_COMPARATOR

standard colonoscopy

Intervention Type: PROCEDURE

examination of the colon with a conventional colonoscope

Interventions

standard colonoscopy

examination of the colon with a conventional colonoscope

Intervention Type: PROCEDURE

Endocuff-assisted colonoscopy

examination of the colon with Endocuff-assisted colonoscopy

Intervention Type: PROCEDURE

Other Intervention Names

conventional colonoscopy; Endocuff

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Attikon Hospital

OTHER

Sponsor Role: lead

Responsible Party

ATHANASIOS SIOULAS

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KONSTANTINOS TRIANTAFYLLOU, PROF

Role: STUDY_CHAIR

Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece

DIMITRIOS POLYMEROS, MD

Role: STUDY_DIRECTOR

Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece

Locations

Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital

Haidari, Attica, Greece

Countries

Greece

References

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.

Reference Type: BACKGROUND

PMID: 25470133 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24921209 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28763808 (View on PubMed)

Other Identifiers

ENDOCUFF-001

Identifier Type: -

Identifier Source: org_study_id