title: COMPRES: a prospective postmarketing evaluation of the compression anastomosis ring CAR 27(™) /ColonRing(™).
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Abdominal Surgery, University Hospital Gasthuisberg Leuven, Leuven, Belgium.
authors.forename: A
authors.initials: A
authors.lastname: D'Hoore
authors.affiliation: Center for Colon and Rectal Surgery, Altamonte Springs and Florida Hospital, Orlando, Florida, USA.
authors.forename: M R
authors.initials: MR
authors.lastname: Albert
authors.affiliation: Southern Regional Medical Center, Spivey Station Surgery Center, Emory Healthcare, Atlanta, Georgia, USA.
authors.forename: S M
authors.initials: SM
authors.lastname: Cohen
authors.affiliation: Abteilung für Chirurgie, Barmherzige Brueder, Krankenhaus Wien, Vienna, Austria.
authors.forename: F
authors.initials: F
authors.lastname: Herbst
authors.affiliation: Bnai Zion Medical Center, Haifa, Israel.
authors.forename: I
authors.initials: I
authors.lastname: Matter
authors.affiliation: Ziekenhuis Oost Limburg, Genk, Belgium.
authors.forename: K
authors.initials: K
authors.lastname: Van Der Speeten
authors.affiliation: Department of Colorectal Surgery, Ferrell-Duncan Clinic, Springfield, Missouri, USA.
authors.forename: J
authors.initials: J
authors.lastname: Dominguez
authors.affiliation: Catharina Ziekenhuis, Eindhoven, Netherlands.
authors.forename: H
authors.initials: H
authors.lastname: Rutten
authors.affiliation: Section of Colon and Rectal Surgery, NorthShore University Healthsystem and University of Chicago, Pritzker School of Medicine, Chicago, Illinois, USA.
authors.forename: J P
authors.initials: JP
authors.lastname: Muldoon
authors.affiliation: Department of Surgery, University of Nevada School of Medicine, Las Vegas, Nevada, USA.
authors.forename: O
authors.initials: O
authors.lastname: Bardakcioglu
authors.affiliation: Department of General Surgery, CMU College of Medicine, Saginaw, Missouri, USA.
authors.forename: A J
authors.initials: AJ
authors.lastname: Senagore
authors.affiliation: Klinikum Neuperlach, Department of Coloproctology, Munich, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Ruppert
authors.affiliation: Department of Surgery, Division of Colon and Rectal Surgery, University of California, Irvine, Orange, California, USA.
authors.forename: S
authors.initials: S
authors.lastname: Mills
authors.affiliation: Department of Surgery, University of California, Irvine, Orange, California, USA.
authors.forename: M J
authors.initials: MJ
authors.lastname: Stamos
authors.affiliation: Deparment of Surgical Science, Uppsala University, Uppsala, Sweden.
authors.forename: L
authors.initials: L
authors.lastname: Påhlman
authors.affiliation: novoGI Ltd, Netanya, Israel.
authors.forename: E
authors.initials: E
authors.lastname: Choman
authors.affiliation: Digestive Disease Center, Department of Colorectal Surgery, Cleveland Clinic Florida, Weston, Florida, USA.
authors.forename: S D
authors.initials: SD
authors.lastname: Wexner
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys / Q000627:therapeutic use; D000714:Anastomosis, Surgical / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D057868:Anastomotic Leak / Q000628:therapy*; D003082:Colectomy / Q000379:methods; D003106:Colon / Q000601:surgery*; D005060:Europe; D005260:Female; D006801:Humans; D007557:Israel; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012007:Rectum / Q000601:surgery*; D018805:Sepsis / Q000453:epidemiology / Q000209:etiology; D014481:United States; D055815:Young Adult
chemical_list: D000497:Alloys; C013616:nitinol
keywords: Compression anastomosis; anastomotic leakage; low anterior resection