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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.

Manual circular staplers are widely used in colorectal surgery; however, limited literature exists examining complications related to circular anastomoses when such devices are used. The present study evaluated the incidence, predictors, and economic burden of circular anastomotic complications in left-sided colorectal reconstructions involving manual circular staplers. Patients aged ≥18 years who underwent hemicolectomy, low anterior resection, or sigmoidectomy between 1 October 2016 and 31 December 2018 were identified from the Premier Healthcare Database. Manual circular stapler use was identified from hospital administrative billing records. Circular anastomotic complications were defined as a composite endpoint of multiple circular stapler use (proxy for stapler failure) or other circular anastomotic complications (anastomotic leak, bleeding, device/surgical complications, infection, and transfusion). Multivariable analyses were used to model the associations between circular anastomotic complications and total hospital costs, length of stay, operating room time, and 30-, 60-, and 90-day readmission rates. A total of 13,167 patients met the study criteria, of whom 2,984 (22.7%) had circular anastomotic complications. Predictors of circular anastomotic complications included age, procedure type, provider region, and select patient comorbidities. As compared with those who did not, patients who suffered circular anastomotic complications had significantly higher adjusted total hospital costs ($26,924 vs. $18,748; p p p p p p p The present study is limited by the observational nature and potential for measurement error that is inherent to administrative healthcare databases. In this analysis of patients undergoing left-sided colorectal reconstructions involving a manual circular stapler, circular anastomotic complications were associated with adverse economic consequences.

Background: An advanced bipolar (ABP) tissue sealer designed for division of major vessels in open procedures was evaluated in a prospective post-market study. The objective was to provide clinical data for assessment of vessel transection, hemostatic performance and ease of use of the ABP device duringopen colectomy, gynecologic, and thoracic operations.Materials and methods: The ABP test device was used in colectomy (n ¼ 36), gynecologic (n ¼ 44), and thoracic (n ¼ 21) procedure groups. Vessels transected with the ABP device were graded intraoperatively on a hemostasis scale of 1e4, defined as follows: Grade1, no bleeding; Grade 2, minor bleeding with no intervention; Grade 3, minor bleeding requiring touchup with the test device or monopolar cautery; and Grade 4, significant bleeding requiring intervention with any additional hemostatic product. The primaryperformance measure was the percentage of vessels that achieved hemostasis grades 3. The primary safety endpoint was the summarization of all ABP device-related adverse events (AEs).Results: For all three procedure groups together, 302 (96.2%) of 314 total vessel transections were scored as hemostasis grades 3, including 270 (86.0%) that were rated Grade 1. Twelve transections (3.8%) were Grade 4, which included 9 vessels transected in the gynecologic group and 3 in the thoracic group. Threesubjects experienced a total of 4 device-related AEs, consisting of hematoma, hypotension, procedural pain, and superficial thermal burn. All 4 device-related AEs were mild in severity.Conclusion: The advanced bipolar device exhibited effective hemostasis, an acceptable safety profile, and ease of use during colectomy, thoracic, and gynecologic procedures.Trial registry number: ClinicalTrials.gov, NCT034411.

Background A narrow-profile powered vascular stapler (PVS) was developed to provide superior access and precise staple placement in thoracic procedures. The objective of this study was to determine if the PVS would yield an equivalent rate of hemostatic interventions compared with standard of care (SOC) staplers in video-assisted thoracoscopic surgery lobectomy. Materials and Methods A randomized, controlled, multicenter study was conducted comparing PVS with SOC staplers in lobectomies performed for non–small cell lung cancer. The primary performance endpoint was the incidence of intraoperative hemostatic interventions, and the primary safety endpoint was the frequency of postoperative bleeding-related interventions. Results A total of 98 subjects participated in the SOC group and 103 in the PVS group. Rates of intraoperative hemostatic interventions were 5.3% and 8.3% for the SOC and PVS groups, respectively. These rates were not statistically different (P = 0.137), although the upper bound of the 95% confidence interval for the difference in intervention rates between PVC and SOC exceeded a predefined 3% criterion for equivalence. Simple compressions were performed more frequently in the PVS subjects, which accounted for the higher intervention rate in this group. Postoperative interventions for bleeding were required in one SOC subject (1.0%) and one subject from the PVS group (0.9%). Procedure-related adverse events occurred in 21 (21.9%) SOC subjects and 23 (21.9%) PVS subjects, with no adverse events related to use of the study devices. Conclusions The PVS exhibited similar overall safety and effectiveness to SOC staplers in video-assisted thoracoscopic surgery lobectomy.