NCT02838186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
674

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

7 months

First QC Date

June 19, 2013

Last Update Submit

July 16, 2016

Conditions

Keywords

colonoscopyright colon retroflexionadenoma detection ratefeasibilitysurveillance interval

Outcome Measures

Primary Outcomes (1)

  • number of additional identified polyps with right colon scope retroflexion

    one week

Secondary Outcomes (2)

  • Change in colorectal cancer (CRC) surveillance intervals among screening-surveillance patients

    one week

  • Rate of retroflexion-related adverse events.

    one week

Study Arms (2)

right colon in retroflexion

ACTIVE COMPARATOR

* polyp/adenoma detection * feasibility

Procedure: retroflexion

right colon in forward view

ACTIVE COMPARATOR

polyp/adenoma detection

Procedure: forward view

Interventions

retroflexionPROCEDURE

examination of the right colon with scope retroflexion

right colon in retroflexion
forward viewPROCEDURE

examination of the right colon in forward view

right colon in forward view

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Attikon University General Hospital

Haidari, Attica, 12462, Greece

Location

Related Publications (2)

  • 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.

    PMID: 16454841BACKGROUND
  • Vemulapalli KC, Rex DK. Evolving techniques in colonoscopy. Curr Opin Gastroenterol. 2011 Sep;27(5):430-8. doi: 10.1097/MOG.0b013e328349cfc0.

    PMID: 21785352BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Konstantinos Triantafyllou, Prof

    Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 19, 2013

First Posted

July 20, 2016

Study Start

May 1, 2013

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations