Endocuff-assisted vs. Standard Colonoscopy

Colon Neoplasms Clinical Trial

Official title:

Endocuff-assisted vs. Standard Colonoscopy: a Randomized, Back-to-Back Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340065
• Other study ID #: ENDOCUFF-001
• Status: Completed
• Phase: N/A
• First received: January 13, 2015
• Last updated: July 13, 2016
• Start date: January 2015
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colon Neoplasms
• Colonic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Greece	Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital	Haidari	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number and rate of missed adenomas	in the entire colon	one week	No
Secondary	number of adenomas and adenoma detection rate in the entire colon	with both Endocuff-assisted and standard colonoscopy	one week	No
Secondary	number of adenomas and adenoma detection rate in the right colon	with both Endocuff-assisted and standard colonoscopy	one week	No
Secondary	number of polyps and polyp detection rate in the entire colon	with both Endocuff-assisted and standard colonoscopy	one week	No
Secondary	number of polyps and polyp detection rate in the right colon	with both Endocuff-assisted and standard colonoscopy	one week	No
Secondary	colonoscopy completion (colonoscopy completion rate, reason for incomplete colonoscopy)	colonoscopy completion rate, reason for incomplete colonoscopy	one week	No
Secondary	intubation and withdrawal time	for both Endocuff-assisted and standard colonoscopy (time spent for therapeutic procedures is excluded)	one week	No
Secondary	adverse events	adverse event rate	one week	Yes
Secondary	endoscopist's satisfaction (quantified using a scale from 0 (not satisfied) to 10 (completely satisfied)	endoscopist's satisfaction quantified using a scale from 0 (not satisfied) to 10 (completely satisfied) for Endocuff-assisted colonoscopy	one week	No
Secondary	mean number of adenomas per procedure	with both Endocuff-assisted and standard colonoscopy	one week	No