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Clinical Trial
. 2015 Jun;17(6):522-9.
doi: 10.1111/codi.12884.

COMPRES: a prospective postmarketing evaluation of the compression anastomosis ring CAR 27(™) /ColonRing(™)

A D'Hoore  1 , M R Albert  2 , S M Cohen  3 , F Herbst  4 , I Matter  5 , K Van Der Speeten  6 , J Dominguez  7 , H Rutten  8 , J P Muldoon  9 , O Bardakcioglu  10 , A J Senagore  11 , R Ruppert  12 , S Mills  13 , M J Stamos  14 , L Påhlman  15 , E Choman  16 , S D Wexner  17 ; COMPRES collaborative study group
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Free article
Clinical Trial

COMPRES: a prospective postmarketing evaluation of the compression anastomosis ring CAR 27(™) /ColonRing(™)

A D'Hoore et al. Colorectal Dis. 2015 Jun.
Free article

Abstract

Aim: Preclinical studies have suggested that nitinol-based compression anastomosis might be a viable solution to anastomotic leak following low anterior resection. A prospective multicentre open label study was therefore designed to evaluate the performance of the ColonRing(™) in (low) colorectal anastomosis.

Method: The primary outcome measure was anastomotic leakage. Patients were recruited at 13 different colorectal surgical units in Europe, the United States and Israel. Institutional review board approval was obtained.

Results: Between 21 March 2010 and 3 August 2011, 266 patients completed the study protocol. The overall anastomotic leakage rate was 5.3% for all anastomoses, including a rate of 3.1% for low anastomoses. Septic anastomotic complications occurred in 8.3% of all anastomoses and 8.2% of low anastomoses.

Conclusion: Nitinol compression anastomosis is safe, effective and easy to use and may offer an advantage for low colorectal anastomosis. A prospective randomized trial comparing ColonRing(™) with conventional stapling is needed.

Keywords: Compression anastomosis; anastomotic leakage; low anterior resection.

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