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

D'Hoore, A., Albert, M. R., Cohen, S. M., Herbst, F., Matter, I., Van der Speeten, K., Dominguez, J., Rutten, H., Muldoon, J. P., Bardakcioglu, O., Senagore, A. J., Ruppert, R., Mills, S., Stamos, M. J., Pahlman, L., Choman, E., Wexner, S. D., COMPRES Collaborative Study Grp

MJS: Grant Support/Consulting fees/Honorarium: Ethicon, NiTi/NovoGI, Novadaq, Gore, Olympus. SM: Consultant, Ethicon Endosurgery. JPM: None. SMC: Speakers panel for Pacira. MRA: Consultant applied medical, Speaker/proctor Novadaq, Speaker/proctor Medtronic, Speaker Lifecell. JD: None. AJS: Advisory Board Ethicon Endosurgery. SDW has received from novoGI consulting fees as a paid consultant and has received stock options and inventor's income for intellectual property license after study closure. LP has received from novoGI consulting fees from NovoGI as a paid consultant. OB: None.

AimPreclinical 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. MethodThe 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. ResultsBetween 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. ConclusionNitinol 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.

COMPRES: a prospective postmarketing evaluation of the compression anastomosis ring CAR 27/ColonRing Article