1. COMPRES: a prospective postmarketing evaluation of the compression anastomosis ring CAR 27(™) /ColonRing(™).
- Author
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D'Hoore A, Albert MR, Cohen SM, Herbst F, Matter I, Van Der Speeten K, Dominguez J, Rutten H, Muldoon JP, Bardakcioglu O, Senagore AJ, Ruppert R, Mills S, Stamos MJ, Påhlman L, Choman E, and Wexner SD
- Subjects
- Adult, Aged, Aged, 80 and over, Alloys therapeutic use, Anastomosis, Surgical adverse effects, Anastomosis, Surgical methods, Colectomy methods, Europe, Female, Humans, Israel, Male, Middle Aged, Product Surveillance, Postmarketing, Prospective Studies, Sepsis epidemiology, Sepsis etiology, United States, Young Adult, Anastomosis, Surgical instrumentation, Anastomotic Leak therapy, Colon surgery, Rectum surgery
- 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., (Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.)
- Published
- 2015
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