Evaluation of Long-term Performance of the GORE SYNECOR Intraperitoneal Biomaterial in the Treatment of Inguinal Hernias.

Autor:	Grantham DW; Pinehurst Surgical Clinic, Pinehurst., Doerhoff CR; Capital Region Medical Center, Jefferson City, MO., Linn JG; North Shore Medical Group, Evanston, IL., Mallico EJ; Novant Health Bariatric Solutions, Salisbury, NC., Washington RG Jr; Pinehurst Surgical Clinic, Pinehurst.
Jazyk:	angličtina
Zdroj:	Surgical laparoscopy, endoscopy & percutaneous techniques [Surg Laparosc Endosc Percutan Tech] 2023 Jun 01; Vol. 33 (3), pp. 231-234. Date of Electronic Publication: 2023 Jun 01.
DOI:	10.1097/SLE.0000000000001166
Abstrakt:	Background: The objective of this study was to analyze device safety and clinical outcomes of inguinal hernia repair with the GORE SYNECOR Intraperitoneal Biomaterial device, a hybrid composite mesh. Methods: This retrospective case review analyzed device/procedure endpoints beyond 1 year in patients treated for inguinal hernia repair with the device. Three objectives were evaluated: procedural endpoint-incidence through 30 days of surgical site infection, surgical site occurrence (SSO), ileus, readmission, reoperation, and death; device endpoint-serious device incidence of mesh erosion, infection, excision/removal, exposure, migration, shrinkage, device-related bowel obstruction and fistula, and hernia recurrence through 12 months; and patient-reported outcomes of the bulge, physical symptoms, and pain. Results: A total of 157 patients (mean age: 67±13 y) with 201 inguinal hernias (mean size: 5.1±5 cm 2 ) were included. Laparoscopic approach and bridging repair were performed in 99.4% of patients. All device location was preperitoneal. No procedure-related adverse events within 30 days were reported. No surgical site infection or SSO events or device-related hernia recurrence occurred through 12 months. Procedure-related serious adverse events occurred in 6 patients; 5 recurrent inguinal hernias (at 1 and 2 y) and 1 scrotal hematoma (at 6 mo). Through 24 months, no SSO events requiring procedural intervention occurred. Through 50 months, 6 (2.98%) patients had confirmed hernia recurrence and 4 (1.99%) patients had hernia reoperation. The patient-reported outcome for pain was reported by 7.9% (10/126) of patients who completed the questionnaire. Conclusions: In this study, inguinal hernia repair with the hybrid composite mesh was successful in most patients and the rate of recurrence was low, further supporting the long-term safety and device performance. Competing Interests: J.G.L. has received research support and speaking and teaching honorarium from W. L. Gore & Associates Inc. C.R.D. has received consultancy fees from W. L. Gore & Associates Inc. The remaining authors declare no conflicts of interest. (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)
Databáze:	MEDLINE
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