Endocuff-assisted vs. Standard Colonoscopy

July 13, 2016 updated by: ATHANASIOS SIOULAS, Attikon Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attica
      • Haidari, Attica, Greece, 12462
        • Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard colonoscopy
total polyp/adenoma detection with standard colonoscopy, polyp/adenoma detection in the right colon with standard colonoscopy
Procedure: Endocuff-assisted colonoscopy
examination of the colon with Endocuff-assisted colonoscopy
Other Names:
  • Endocuff
Active Comparator: Endocuff-assisted colonoscopy
total polyp/adenoma detection with Endocuff-assisted colonoscopy, polyp/adenoma detection in the right colon with Endocuff-assisted colonoscopy
Procedure: standard colonoscopy
examination of the colon with a conventional colonoscope
Other Names:
  • conventional colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number and rate of missed adenomas
Time Frame: one week
in the entire colon
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of adenomas and adenoma detection rate in the entire colon
Time Frame: one week
with both Endocuff-assisted and standard colonoscopy
one week
number of adenomas and adenoma detection rate in the right colon
Time Frame: one week
with both Endocuff-assisted and standard colonoscopy
one week
number of polyps and polyp detection rate in the entire colon
Time Frame: one week
with both Endocuff-assisted and standard colonoscopy
one week
number of polyps and polyp detection rate in the right colon
Time Frame: one week
with both Endocuff-assisted and standard colonoscopy
one week
colonoscopy completion (colonoscopy completion rate, reason for incomplete colonoscopy)
Time Frame: one week
colonoscopy completion rate, reason for incomplete colonoscopy
one week
intubation and withdrawal time
Time Frame: one week
for both Endocuff-assisted and standard colonoscopy (time spent for therapeutic procedures is excluded)
one week
adverse events
Time Frame: one week
adverse event rate
one week
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
one week
mean number of adenomas per procedure
Time Frame: one week
with both Endocuff-assisted and standard colonoscopy
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Attikon Hospital

Investigators

  • Study Chair: KONSTANTINOS TRIANTAFYLLOU, PROF, Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece
  • Study Director: DIMITRIOS POLYMEROS, MD, Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 15, 2015

First Posted (Estimate)

January 16, 2015

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDOCUFF-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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