A D'Hoore1, M R Albert2, S M Cohen3, F Herbst4, I Matter5, K Van Der Speeten6, J Dominguez7, H Rutten8, J P Muldoon9, O Bardakcioglu10, A J Senagore11, R Ruppert12, S Mills13, M J Stamos14, L Påhlman15, E Choman16, S D Wexner17. 1. Department of Abdominal Surgery, University Hospital Gasthuisberg Leuven, Leuven, Belgium. 2. Center for Colon and Rectal Surgery, Altamonte Springs and Florida Hospital, Orlando, Florida, USA. 3. Southern Regional Medical Center, Spivey Station Surgery Center, Emory Healthcare, Atlanta, Georgia, USA. 4. Abteilung für Chirurgie, Barmherzige Brueder, Krankenhaus Wien, Vienna, Austria. 5. Bnai Zion Medical Center, Haifa, Israel. 6. Ziekenhuis Oost Limburg, Genk, Belgium. 7. Department of Colorectal Surgery, Ferrell-Duncan Clinic, Springfield, Missouri, USA. 8. Catharina Ziekenhuis, Eindhoven, Netherlands. 9. Section of Colon and Rectal Surgery, NorthShore University Healthsystem and University of Chicago, Pritzker School of Medicine, Chicago, Illinois, USA. 10. Department of Surgery, University of Nevada School of Medicine, Las Vegas, Nevada, USA. 11. Department of General Surgery, CMU College of Medicine, Saginaw, Missouri, USA. 12. Klinikum Neuperlach, Department of Coloproctology, Munich, Germany. 13. Department of Surgery, Division of Colon and Rectal Surgery, University of California, Irvine, Orange, California, USA. 14. Department of Surgery, University of California, Irvine, Orange, California, USA. 15. Deparment of Surgical Science, Uppsala University, Uppsala, Sweden. 16. novoGI Ltd, Netanya, Israel. 17. Digestive Disease Center, Department of Colorectal Surgery, Cleveland Clinic Florida, Weston, Florida, USA.
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
RCT Entities:
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
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