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

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

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.

Publication types

  • Clinical Trial, Phase IV
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Alloys / therapeutic use
  • Anastomosis, Surgical / adverse effects
  • Anastomosis, Surgical / instrumentation*
  • Anastomosis, Surgical / methods
  • Anastomotic Leak / therapy*
  • Colectomy / methods
  • Colon / surgery*
  • Europe
  • Female
  • Humans
  • Israel
  • Male
  • Middle Aged
  • Product Surveillance, Postmarketing
  • Prospective Studies
  • Rectum / surgery*
  • Sepsis / epidemiology
  • Sepsis / etiology
  • United States
  • Young Adult

Substances

  • Alloys
  • nitinol