Electrospun P(LLA-CL) Nanoscale Fibrinogen Patch vs Porcine Small Intestine Submucosa Graft Repair of Inguinal Hernia in Adults: A Randomized, Single-Blind, Controlled, Multicenter, Noninferiority Trial
| Autor: | Hongbing He, Shaojie Li, Hongbing Xiao, Zhiying Qiu, Jiangxiong Tang, Lei Hua, Ding Ping, Li Yang, Xingchen Hu, Kan Zheng |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Swine medicine.medical_treatment Hernia Inguinal Hemostatics law.invention Young Adult Randomized controlled trial law Multicenter trial Intestine Small Clinical endpoint Medicine Animals Humans Hernia Single-Blind Method Intestinal Mucosa Herniorrhaphy Aged Retrospective Studies Groin business.industry Fibrinogen Retrospective cohort study Middle Aged Hernia repair medicine.disease Surgery Inguinal hernia medicine.anatomical_structure Treatment Outcome Female business Follow-Up Studies |
| Zdroj: | Journal of the American College of Surgeons. 229(6) |
| ISSN: | 1879-1190 |
| Popis: | The aim of this study was to compare primary efficacy indicators of a low-cost, electrospun, nanoscale P(LLA-CL)/fibrinogen patch with a porcine small intestine submucosa patch for hernia repair.A randomized, single-blind, controlled multicenter trial was performed in 3 hospitals in Shanghai. Eligible patients (20 to 75 years old) with primary unilateral, reducible groin hernias were randomly assigned (1:1) to electrospun nanoscale P(LLA-CL)/fibrinogen patch (experimental group) or porcine small intestine submucosa (control group) patch groups. Patients were treated with the Lichtenstein technique, and the primary endpoint was hernia recurrence at 33 months after surgery. The secondary endpoints were postoperative complications including groin pain and operative site infections.Between July 2014 and February 2016, 172 patients were assigned to experimental (n = 86) and control (n = 86) groups. At 6-month follow-up, postoperative complications occurred in 5 patients (5 of 86, 5.81%) and 2 (2 of 86, 2.35%) patients in the control and experimental groups, respectively (p0.05). At 33-month follow-up, recurrence was observed in 2 patients (2 of 79, 2.53%) in the control group vs none in the experimental group (0 of 78) (the 95% CI difference between the experimental and control groups was -0.93% to 6.00% and within the preset noninferior margin of Δ10%). No significant differences were found in the degree of chronic pain and complications 33 months after surgery between the 2 groups.Because the recurrence rates and postoperative complications after 33 months were not inferior in the experimental group, we believe that the P(LLA-CL)/fibrinogen patch, as a low cost alternative, has prospects for widespread clinical use. |
| Databáze: | OpenAIRE |
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