Endocuff-assisted vs. Standard Colonoscopy

Attikon University Hospital

Status: Completed

Conditions: Colon Neoplasms

Treatments: Procedure: standard colonoscopy; Procedure: Endocuff-assisted colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02340065

ENDOCUFF-001

Details and patient eligibility

About

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 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

standard colonoscopy

Active Comparator group

Description:

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

Treatment:

Procedure: Endocuff-assisted colonoscopy

Endocuff-assisted colonoscopy

Active Comparator group

Description:

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

Treatment:

Procedure: standard colonoscopy