- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02838186
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
-
-
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
|
examination of the right colon with scope retroflexion
|
Active Comparator: right colon in forward view
polyp/adenoma detection
|
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
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
- van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x.
- Vemulapalli KC, Rex DK. Evolving techniques in colonoscopy. Curr Opin Gastroenterol. 2011 Sep;27(5):430-8. doi: 10.1097/MOG.0b013e328349cfc0.
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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