TY - JOUR
T1 - Assessment of a circular powered stapler for creation of anastomosis in left-sided colorectal surgery
T2 - A prospective cohort study
AU - Herzig, Daniel O.
AU - Ogilvie, James W.
AU - Chudzinski, Allen
AU - Ferrara, Andrea
AU - Ashraf, Shazad Q.
AU - Jimenez-Rodriguez, Rosa M.
AU - Van der Speeten, Kurt
AU - Kinross, James
AU - Schimmelpenning, Hendrik
AU - Sagar, Peter M.
AU - Cannon, Jamie A.
AU - Schwiers, Michael L.
AU - Singleton, David W.
AU - Waggoner, Jason R.
AU - Fryrear, Raymond
AU - Sylla, Patricia
N1 - Publisher Copyright:
© 2020 IJS Publishing Group Ltd
PY - 2020/12
Y1 - 2020/12
N2 - Background: Circular staplers perform a critical function for creation of anastomoses in colorectal surgeries. Powered stapling systems allow for reduced force required by surgeons to fire the device and may provide advantages for creating a secure anastomosis. The objective of this study was to evaluate the clinical performance of a novel circular powered stapler in a post-market setting, during left-sided colectomy procedures. Materials and methods: Consecutive subjects underwent left-sided colorectal resections that included anastomosis performed with the ECHELON CIRCULAR™ Powered Stapler (ECP). The primary endpoint was the frequency in which a stapler performance issue was observed. Secondary endpoints included evaluation of ease of use of the device via a surgeon satisfaction questionnaire, and monitoring/recording of procedure-related adverse events (AEs). Results: A total of 168 anastomoses were performed with the ECP. Surgical approaches included robotic-assisted (n = 74, 44.0%), laparoscopic (n = 71, 42.3%), open (n = 20, 11.9%), and hand-assisted minimally invasive (n = 3, 1.8%) procedures. There were 22 occurrences of device performance issues in 20 (11.9%) subjects during surgery. No positive intraoperative leak tests were observed, and only 1 issue was related to a procedure-related AE or surgical complication, which was an instance of incomplete surgical donut necessitating re-anastomosis. Postoperative anastomotic leaks were experienced in 4 (2.4%) subjects. Clavien-Dindo classification of all AEs indicated that 92.0% were Grades I or II. Participating surgeons rated the ECP as easier to use compared to previously used manual circular staplers in 85.7% of procedures. Conclusion: The circular powered stapler exhibited few clinically relevant performance issues, an overall favorable safety profile, and ease of use for creation of left-sided colon anastomoses.
AB - Background: Circular staplers perform a critical function for creation of anastomoses in colorectal surgeries. Powered stapling systems allow for reduced force required by surgeons to fire the device and may provide advantages for creating a secure anastomosis. The objective of this study was to evaluate the clinical performance of a novel circular powered stapler in a post-market setting, during left-sided colectomy procedures. Materials and methods: Consecutive subjects underwent left-sided colorectal resections that included anastomosis performed with the ECHELON CIRCULAR™ Powered Stapler (ECP). The primary endpoint was the frequency in which a stapler performance issue was observed. Secondary endpoints included evaluation of ease of use of the device via a surgeon satisfaction questionnaire, and monitoring/recording of procedure-related adverse events (AEs). Results: A total of 168 anastomoses were performed with the ECP. Surgical approaches included robotic-assisted (n = 74, 44.0%), laparoscopic (n = 71, 42.3%), open (n = 20, 11.9%), and hand-assisted minimally invasive (n = 3, 1.8%) procedures. There were 22 occurrences of device performance issues in 20 (11.9%) subjects during surgery. No positive intraoperative leak tests were observed, and only 1 issue was related to a procedure-related AE or surgical complication, which was an instance of incomplete surgical donut necessitating re-anastomosis. Postoperative anastomotic leaks were experienced in 4 (2.4%) subjects. Clavien-Dindo classification of all AEs indicated that 92.0% were Grades I or II. Participating surgeons rated the ECP as easier to use compared to previously used manual circular staplers in 85.7% of procedures. Conclusion: The circular powered stapler exhibited few clinically relevant performance issues, an overall favorable safety profile, and ease of use for creation of left-sided colon anastomoses.
KW - Anastomosis
KW - Anastomotic leak
KW - Circular stapler
KW - Colectomy
KW - Colorectal
KW - Powered stapler
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U2 - 10.1016/j.ijsu.2020.11.001
DO - 10.1016/j.ijsu.2020.11.001
M3 - Article
C2 - 33176211
AN - SCOPUS:85096219266
SN - 1743-9191
VL - 84
SP - 140
EP - 146
JO - International Journal of Surgery
JF - International Journal of Surgery
ER -