S Atallah1,2, S Kural3, N Banda4, A Banda4, F Bawaney4, F Cabral5, V Neychev4,6, C Patel4,6, S Larach4,6. 1. University of Central Florida, College of Medicine, Orlando, FL, USA. atallah@post.harvard.edu. 2. HCA North Florida Division, Winter Park, FL, 32792, USA. atallah@post.harvard.edu. 3. Uludag University, Bursa, Turkey. 4. University of Central Florida, College of Medicine, Orlando, FL, USA. 5. Instituto Português de Oncologia, Lisbon, Portugal. 6. HCA North Florida Division, Winter Park, FL, 32792, USA.
Abstract
BACKGROUND: The Echelon circular™ powered stapler (ECP stapler) obviates the need for manual firing of conventional circular staplers during the construction of a colorectal anastomosis, but has not been evaluated clinically. The aim of this study was to perform a clinical evaluation of this stapler. METHODS: A retrospective review of the initial clinical experience of a single surgeon using the ECP stapler for left-sided colorectal anastomosis construction during elective colorectal resections for benign and malignant disease was conducted by analyzing results from a prospectively maintained study database. Additionally, four attending colorectal and/or general surgeons who had performed ≥ 5 colorectal operations with the ECP stapler were invited to complete an anonymous online survey to subjectively assess the user experience with the device. Statistical analysis was conducted using Microsoft Excel Version 15.33. RESULTS: Seventeen patients underwent left-sided anastomotic reconstruction using the ECP stapler. All donuts (proximal and distal) were intact. Anastomotic integrity was evaluated using the air-leak test utilizing flexible video sigmoidoscopy. No leaks were observed, although one patient (5.9%) developed a postoperative pelvic abscess. The anonymous survey was completed by all four surgeons. Subjective evaluation of the ECP stapler suggests that the overall stapling quality, overall device ease-of-use, and the overall perception of anastomotic quality as above average when compared to manual 'end-to-end anastomosis' (EEA) stapling devices. CONCLUSIONS: In an initial clinical evaluation of the ECP stapler, the safety and ease-of-use of the device appears to be satisfactory. Powered stapling and the design of '3D stapling' may provide advantages over manual systems, and may improve the construction quality of left-sided colorectal anastomosis.
BACKGROUND: The Echelon circular™ powered stapler (ECP stapler) obviates the need for manual firing of conventional circular staplers during the construction of a colorectal anastomosis, but has not been evaluated clinically. The aim of this study was to perform a clinical evaluation of this stapler. METHODS: A retrospective review of the initial clinical experience of a single surgeon using the ECP stapler for left-sided colorectal anastomosis construction during elective colorectal resections for benign and malignant disease was conducted by analyzing results from a prospectively maintained study database. Additionally, four attending colorectal and/or general surgeons who had performed ≥ 5 colorectal operations with the ECP stapler were invited to complete an anonymous online survey to subjectively assess the user experience with the device. Statistical analysis was conducted using Microsoft Excel Version 15.33. RESULTS: Seventeen patients underwent left-sided anastomotic reconstruction using the ECP stapler. All donuts (proximal and distal) were intact. Anastomotic integrity was evaluated using the air-leak test utilizing flexible video sigmoidoscopy. No leaks were observed, although one patient (5.9%) developed a postoperative pelvic abscess. The anonymous survey was completed by all four surgeons. Subjective evaluation of the ECP stapler suggests that the overall stapling quality, overall device ease-of-use, and the overall perception of anastomotic quality as above average when compared to manual 'end-to-end anastomosis' (EEA) stapling devices. CONCLUSIONS: In an initial clinical evaluation of the ECP stapler, the safety and ease-of-use of the device appears to be satisfactory. Powered stapling and the design of '3D stapling' may provide advantages over manual systems, and may improve the construction quality of left-sided colorectal anastomosis.
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