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

Colon Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838186
• Other study ID #: Retro-2013
• Status: Completed
• Phase: N/A
• First received: June 19, 2013
• Last updated: July 16, 2016
• Start date: May 2013
• Est. completion date: February 2014

Study information

• Verified date: July 2016
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 674
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colon Neoplasms
• Colonic Neoplasms

Intervention

Procedure:
• retroflexion
examination of the right colon with scope retroflexion
• forward view
examination of the right colon in forward view

Locations

Country	Name	City	State
Greece	Attikon University General Hospital	Haidari	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

References & 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. Review. — View Citation

Vemulapalli KC, Rex DK. Evolving techniques in colonoscopy. Curr Opin Gastroenterol. 2011 Sep;27(5):430-8. doi: 10.1097/MOG.0b013e328349cfc0. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of additional identified polyps with right colon scope retroflexion		one week	No
Secondary	Change in colorectal cancer (CRC) surveillance intervals among screening-surveillance patients	change: YES or NO	one week	No
Secondary	Rate of retroflexion-related adverse events.		one week	Yes