دورية أكاديمية
Assessment of a circular powered stapler for creation of anastomosis in left-sided colorectal surgery: A prospective cohort study.
العنوان: | Assessment of a circular powered stapler for creation of anastomosis in left-sided colorectal surgery: A prospective cohort study. |
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المؤلفون: | Herzig DO; Oregon Health and Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA., Ogilvie JW; Spectrum Health, 4100 Lake Dr SE STE 205, Grand Rapids, MI, USA., Chudzinski A; AdventHealth Tampa, 3000 Medical Park Dr #500, Tampa, FL, 33611, USA., Ferrara A; Colon and Rectal Clinic of Orlando, Orlando, FL, USA., Ashraf SQ; University Hospitals Birmingham NHS, Queen Elizabeth Hospital, Mindelsohn Way, Edgbaston, Birmingham, B15 2GW, UK., Jimenez-Rodriguez RM; Hospital Universitario Virgen Del Rocio, Unidad de Coloproctologia, Sevilla, 41013, Spain., Van der Speeten K; Ziekenhuis Oost-Limburg, Schiepse Bos 6, 3600, Genk, Belgium., Kinross J; St. Mary's Hospital, Imperial College London, Praed St, Paddington, London, W2 1NY, UK., Schimmelpenning H; Schon Klinik Neustadt, Am Kiebitzberg 10 D, 23730, Neustadt in Holstein, Germany., Sagar PM; St James's University Hospital, Beckett St, Leeds, LS9 7TF, UK., Cannon JA; University of Alabama Birmingham School of Medicine, 2000 6th Ave S 1st Floor, Birmingham, AL, 35233, USA., Schwiers ML; Ethicon Endo-Surgery, Inc, 4545 Creek Rd, Blue Ash, OH, 45242, USA., Singleton DW; Ethicon Endo-Surgery, Inc, 4545 Creek Rd, Blue Ash, OH, 45242, USA. Electronic address: dsingl12@its.jnj.com., Waggoner JR; Ethicon Endo-Surgery, Inc, 4545 Creek Rd, Blue Ash, OH, 45242, USA., Fryrear R 2nd; Ethicon Endo-Surgery, Inc, 4545 Creek Rd, Blue Ash, OH, 45242, USA., Sylla P; Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, 5 E 98th St 14th Fl, Ste D, New York, NY, 10029, USA. |
المصدر: | International journal of surgery (London, England) [Int J Surg] 2020 Dec; Vol. 84, pp. 140-146. Date of Electronic Publication: 2020 Nov 08. |
نوع المنشور: | Journal Article; Multicenter Study |
اللغة: | English |
بيانات الدورية: | Publisher: Wolters Kluwer Health, Inc Country of Publication: United States NLM ID: 101228232 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1743-9159 (Electronic) Linking ISSN: 17439159 NLM ISO Abbreviation: Int J Surg Subsets: MEDLINE |
أسماء مطبوعة: | Publication: 2023- : [Philadelphia] : Wolters Kluwer Health, Inc. Original Publication: London : Surgical Associates Ltd., c2004- |
مواضيع طبية MeSH: | Surgical Staplers*, Anastomosis, Surgical/*methods , Colectomy/*methods, Adult ; Aged ; Aged, 80 and over ; Anastomosis, Surgical/adverse effects ; Colectomy/adverse effects ; Colectomy/instrumentation ; Female ; Humans ; Male ; Middle Aged ; Prospective Studies |
مستخلص: | 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. (Copyright © 2020 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.) |
التعليقات: | Comment in: Int J Surg. 2021 Jan;85:55-56. (PMID: 33359387) |
فهرسة مساهمة: | Keywords: Anastomosis; Anastomotic leak; Circular stapler; Colectomy; Colorectal; Powered stapler |
تواريخ الأحداث: | Date Created: 20201111 Date Completed: 20210405 Latest Revision: 20210405 |
رمز التحديث: | 20231215 |
DOI: | 10.1016/j.ijsu.2020.11.001 |
PMID: | 33176211 |
قاعدة البيانات: | MEDLINE |
تدمد: | 1743-9159 |
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DOI: | 10.1016/j.ijsu.2020.11.001 |