Backwards Examination of the Right Colon: A Back-to-back Study

July 16, 2016 updated by: ATHANASIOS SIOULAS, Attikon Hospital

Diagnostic Yield of Scope Retroflexion in the Right Colon: A Prospective Cohort Study

The aim of this study is to evaluate the examination of the proximal colon with the retroflexion colonoscopic technique in terms of feasibility and its possible additive contribution in the detection of important lesions, namely polyps and cancers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators prospectively examined the additional diagnostic yield of right colon examination with colonoscope retroflexion in consecutive, symptomatic and screening - surveillance patients. Right colon was examined in forward-view first and thereafter, retroflexion was performed to re-inspect it.

Study Type

Interventional

Enrollment (Actual)

674

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
        • 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:

  • patients undergoing elective colonoscopy in a Attikon University General Hospital.

Exclusion Criteria:

  • patients aged <18 and >80 years;
  • right colectomy;
  • recent abdominalsurgery;
  • multiple diverticula of the right colon;
  • American Society of Anesthesiology (ASA) physical status classification grade IV;
  • inflammatory bowel disease and 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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: right colon in retroflexion
  • polyp/adenoma detection
  • feasibility
Procedure: retroflexion
examination of the right colon with scope retroflexion
Active Comparator: right colon in forward view
polyp/adenoma detection
Procedure: forward view
examination of the right colon in forward view

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of additional identified polyps with right colon scope retroflexion
Time Frame: one week
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in colorectal cancer (CRC) surveillance intervals among screening-surveillance patients
Time Frame: one week
change: YES or NO
one week
Rate of retroflexion-related adverse events.
Time Frame: one week
one week

Collaborators and Investigators

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

Sponsor

Attikon Hospital

Investigators

  • Study Director: Konstantinos Triantafyllou, Prof, 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

May 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

June 19, 2013

First Submitted That Met QC Criteria

July 16, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Estimate)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 16, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Retro-2013

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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