Assessment of a circular powered stapler for creation of anastomosis in left-sided colorectal surgery: A prospective cohort study

• Published in: International journal of surgery (London, England) Vol. 84; pp. 140 - 146
• Main Authors: Herzig, Daniel O., Ogilvie, James W., Chudzinski, Allen, Ferrara, Andrea, Ashraf, Shazad Q., Jimenez-Rodriguez, Rosa M., Van der Speeten, Kurt, Kinross, James, Schimmelpenning, Hendrik, Sagar, Peter M., Cannon, Jamie A., Schwiers, Michael L., Singleton, David W., Waggoner, Jason R., Fryrear, Raymond, Sylla, Patricia
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01-12-2020
• Subjects: Adult; Aged; Aged, 80 and over; Anastomosis; Anastomosis, Surgical - adverse effects; Anastomosis, Surgical - methods; Anastomotic leak; Circular stapler; Colectomy; Colectomy - adverse effects; Colectomy - instrumentation; Colectomy - methods; Colorectal; Female; Humans; Male; Middle Aged; Powered stapler; Prospective Studies; Surgical Staplers; Colectomy; Colorectal; Powered stapler; Circular stapler; Anastomotic leak; Anastomosis
• ISSN: 1743-9191; 1743-9159
• DOI: 10.1016/j.ijsu.2020.11.001

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.
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).
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.
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.
•Test device performance issues occurred in 20 (11.9%) subjects with only one issue requiring surgical revision.•There were zero (0%) intraoperative leaks and 4 (2.4%) postoperative anastomotic leaks among 168 procedures.•The circular powered stapler demonstrated ease of use as judged by investigators.