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

Primary Purpose

Colon Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
retroflexion
forward view
Sponsored by
Attikon Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colon Neoplasms focused on measuring colonoscopy, right colon retroflexion, adenoma detection rate, feasibility, surveillance interval

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Attikon University General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

right colon in retroflexion

right colon in forward view

Arm Description

polyp/adenoma detection feasibility

polyp/adenoma detection

Outcomes

Primary Outcome Measures

number of additional identified polyps with right colon scope retroflexion

Secondary Outcome Measures

Change in colorectal cancer (CRC) surveillance intervals among screening-surveillance patients
change: YES or NO
Rate of retroflexion-related adverse events.

Full Information

First Posted
June 19, 2013
Last Updated
July 16, 2016
Sponsor
Attikon Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02838186
Brief Title
Backwards Examination of the Right Colon: A Back-to-back Study
Official Title
Diagnostic Yield of Scope Retroflexion in the Right Colon: A Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Attikon Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Neoplasms
Keywords
colonoscopy, right colon retroflexion, adenoma detection rate, feasibility, surveillance interval

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
674 (Actual)

8. Arms, Groups, and Interventions

Arm Title
right colon in retroflexion
Arm Type
Active Comparator
Arm Description
polyp/adenoma detection feasibility
Arm Title
right colon in forward view
Arm Type
Active Comparator
Arm Description
polyp/adenoma detection
Intervention Type
Procedure
Intervention Name(s)
retroflexion
Intervention Description
examination of the right colon with scope retroflexion
Intervention Type
Procedure
Intervention Name(s)
forward view
Intervention Description
examination of the right colon in forward view
Primary Outcome Measure Information:
Title
number of additional identified polyps with right colon scope retroflexion
Time Frame
one week
Secondary Outcome Measure Information:
Title
Change in colorectal cancer (CRC) surveillance intervals among screening-surveillance patients
Description
change: YES or NO
Time Frame
one week
Title
Rate of retroflexion-related adverse events.
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantinos Triantafyllou, Prof
Organizational Affiliation
Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece
Official's Role
Study Director
Facility Information:
Facility Name
Attikon University General Hospital
City
Haidari
State/Province
Attica
ZIP/Postal Code
12462
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
16454841
Citation
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.
Results Reference
background
PubMed Identifier
21785352
Citation
Vemulapalli KC, Rex DK. Evolving techniques in colonoscopy. Curr Opin Gastroenterol. 2011 Sep;27(5):430-8. doi: 10.1097/MOG.0b013e328349cfc0.
Results Reference
background

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

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