Endoscopy 2015; 47(12): 1151-1158
DOI: 10.1055/s-0034-1392421
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Multicenter, randomized, tandem evaluation of EndoRings colonoscopy – results of the CLEVER study

Vincent K. Dik
1   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
,
Ian M. Gralnek
2   Institute of Gastroenterology and Liver Diseases, Ha’Emek Medical Center, Afula, Israel
3   GI Endoscopy Unit, Elisha Hospital, Haifa, Israel
4   Rappaport Family Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel
,
Ori Segol
3   GI Endoscopy Unit, Elisha Hospital, Haifa, Israel
5   Department of Gastroenterology, Lady Davis Carmel Medical Center, Haifa, Israel
,
Alain Suissa
3   GI Endoscopy Unit, Elisha Hospital, Haifa, Israel
6   Department of Gastroenterology, Rambam Health Care Campus, Haifa, Israel
,
Tim D. G. Belderbos
1   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
,
Leon M. G. Moons
1   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
,
Meytal Segev
7   EndoAid Ltd., Caesarea, Israel
,
Sveta Domanov
3   GI Endoscopy Unit, Elisha Hospital, Haifa, Israel
,
Douglas K. Rex
8   Department of Medicine, Division of Gastroenterology and Hepatology, Indiana University Hospital, Indianapolis, IN, United States
,
Peter D. Siersema
1   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
› Author Affiliations
Further Information

Publication History

submitted 24 January 2015

accepted after revision 29 April 2015

Publication Date:
28 July 2015 (online)

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Background and study aims: Adenoma miss rate during colonoscopy has become a widely acknowledged proxy measure for post-colonoscopy colorectal cancer. Among other reasons, this can happen because of inadequate visualization of the proximal aspects of colonic folds and flexures. EndoRings (EndoAid Ltd., Caesarea, Israel) is a silicone-rubber device that is fitted onto the distal end of the colonoscope. Its flexible circular rings engage and mechanically stretch colonic folds during withdrawal. The primary aim of this study was to compare adenoma miss rates between standard colonoscopy and colonoscopy using EndoRings.

Methods: In this multicenter, randomized, tandem colonoscopy study, we performed same-day, back-to-back colonoscopies with EndoRings followed by standard colonoscopy, or vice versa.

Results: After exclusion of 10 patients for protocol violations, 116 patients (38.8 % female; mean age 58.7) remained for analysis. The adenoma miss rate of EndoRings colonoscopy (7/67; 10.4 %) was significantly lower (P < 0.001) compared with standard colonoscopy (28/58; 48.3 %). Similar results were found for polyp miss rates: EndoRings (9.1 %) and standard colonoscopy (52.8 %; P < 0.001). Mean cecal intubation times (9.3 vs. 8.4 minutes; P = 0.142) and withdrawal times (7.4 vs. 7.2 minutes; P = 0.286), respectively, were not significantly different between EndoRings and standard colonoscopy. Mean total procedure time was longer with EndoRings than with standard colonoscopy (21.6 vs. 18.5 minutes, P = 0.001) as more polyps were removed.

Conclusions: This study demonstrates that colonoscopy with EndoRings has lower adenoma and polyp miss rates than standard colonoscopy, which may improve the efficacy particularly of screening and surveillance colonoscopies.

ClinicalTrials.gov NCT01955122.

Table e4, e6