Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial

PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.

Abstract

Objectives: The Endocuff is a device mounted on the tip of the colonoscope to help flatten the colonic folds during withdrawal. This study aimed to compare the adenoma detection rates between Endocuff-assisted (EC) colonoscopy and standard colonoscopy (SC).

Methods: This randomized prospective multicenter trial was conducted at four academic endoscopy units in Germany.

Participants: 500 patients (235 males, median age 64[IQR 54-73]) for colon adenoma detection purposes were included in the study. All patients were either allocated to EC or SC. The primary outcome measure was the determination of the adenoma detection rates (ADR).

Results: The ADR significantly increased with the use of the Endocuff compared to standard colonoscopy (35.4%[95% confidence interval{CI} 29-41%] vs. 20.7%[95%CI 15-26%], p<0.0001). Significantly more sessile polyps were detected by EC. Overall procedure time and withdrawal time did not differ. Caecal and ileum intubation rates were similar. No major adverse events occurred in both groups. In multivariate analysis, age (odds ratio [OR] 1.03; 95%[CI] 1.01-1.05), male sex (OR 1.74; 95%CI 1.10-2.73), withdrawal time (OR 1.16; 95%CI 1.05-1.30), procedure time (OR 1.07; 95%CI 1.04-1.10), colon cleanliness (OR 0.60; 95%CI 0.39-0.94) and use of Endocuff (OR 2.09; 95%CI 1.34-3.27) were independent predictors of adenoma detection rates.

Conclusions: EC increases the adenoma detection rate by 14.7%(95%CI 6.9-22.5%). EC is safe, effective, easy to handle and might reduce colorectal interval carcinomas.

Trial registration: ClinicalTrials.gov NCT02034929.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenoma / diagnosis*
  • Aged
  • Colonic Neoplasms / diagnosis*
  • Colonoscopes*
  • Colonoscopy
  • False Negative Reactions
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies

Associated data

  • ClinicalTrials.gov/NCT02034929

Grants and funding

This study was supported by the HELIOS Research Centre, Grant ID 003053 (www.helios-wissen.de/hrc). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.