Daniel O Herzig1, James W Ogilvie2, Allen Chudzinski3, Andrea Ferrara4, Shazad Q Ashraf5, Rosa M Jimenez-Rodriguez6, Kurt Van der Speeten7, James Kinross8, Hendrik Schimmelpenning9, Peter M Sagar10, Jamie A Cannon11, Michael L Schwiers12, David W Singleton13, Jason R Waggoner12, Raymond Fryrear12, Patricia Sylla14. 1. Oregon Health and Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA. 2. Spectrum Health, 4100 Lake Dr SE STE 205, Grand Rapids, MI, USA. 3. AdventHealth Tampa, 3000 Medical Park Dr #500, Tampa, FL, 33611, USA. 4. Colon and Rectal Clinic of Orlando, Orlando, FL, USA. 5. University Hospitals Birmingham NHS, Queen Elizabeth Hospital, Mindelsohn Way, Edgbaston, Birmingham, B15 2GW, UK. 6. Hospital Universitario Virgen Del Rocio, Unidad de Coloproctologia, Sevilla, 41013, Spain. 7. Ziekenhuis Oost-Limburg, Schiepse Bos 6, 3600, Genk, Belgium. 8. St. Mary's Hospital, Imperial College London, Praed St, Paddington, London, W2 1NY, UK. 9. Schon Klinik Neustadt, Am Kiebitzberg 10 D, 23730, Neustadt in Holstein, Germany. 10. St James's University Hospital, Beckett St, Leeds, LS9 7TF, UK. 11. University of Alabama Birmingham School of Medicine, 2000 6th Ave S 1st Floor, Birmingham, AL, 35233, USA. 12. Ethicon Endo-Surgery, Inc, 4545 Creek Rd, Blue Ash, OH, 45242, USA. 13. Ethicon Endo-Surgery, Inc, 4545 Creek Rd, Blue Ash, OH, 45242, USA. Electronic address: dsingl12@its.jnj.com. 14. Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, 5 E 98th St 14th Fl, Ste D, New York, NY, 10029, USA.
Abstract
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.
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.
Authors: Patricia Sylla; Peter Sagar; Stephen S Johnston; Harikumaran R Dwarakanathan; Jason R Waggoner; Michael Schwiers; Sanjoy Roy Journal: Surg Endosc Date: 2021-05-24 Impact factor: 4.584