Randomized Controlled Trial Of Lichtenstein Repair Of Indirect Inguinal Hernias With Two Biologic Meshes From Porcine Small Intestine Submucosa
Authors Sun L, Chen J, Shen Y
Received 10 March 2019
Accepted for publication 13 September 2019
Published 31 October 2019 Volume 2019:15 Pages 1277—1282
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Professor Deyun Wang
Li Sun, Jie Chen, Yingmo Shen
Department of Hernia and Abdominal Wall Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100043, People’s Republic of China
Correspondence: Yingmo Shen
Department of Hernia and Abdominal Wall Surgery, Beijing Chaoyang Hospital, No. 5 Jingyuan Road, Shijingshan District, Beijing 100043, People’s Republic of China
Background: Biologic mesh is a newly developed material for hernia repairs which has been successfully used in clinical practices. This study aims to evaluate the clinical efficacy between patients undergoing a Lichtenstein’s hernioplasty with a new biologic mesh derived from porcine small intestine submucosal (SIS) extracellular matrix versus a standard SIS mesh.
Methods: A prospective, randomized, double-blinded, multi-center trial was conducted in a 6-month study. Lichtenstein hernioplasty was performed using the new SIS mesh (Beijing Biosis Healing Biotechnology) or the standard SIS mesh (Biodesign Surgisis, Cook Biotech). The postoperative follow-up examinations were carried out at during hospitalization, 1st week, 1st, 3rd, and 6th month after surgery. The primary outcome was the excellent and good rate of recovery. Secondary outcomes included recurrence rate, complications, and patient-centered outcomes.
Results: A total of 194 patients were randomized into experimental group receiving the new SIS mesh (n=97) and control group receiving the standard SIS mesh (n=97). The excellent and good rate of rehabilitation in the experimental group was 98.97%, while it was 100.00% in the control group (P>0.05). One patient had a recurrence in the experimental group, while there was no recurrence in the control group (P>0.05). Other clinical outcomes, including the length of operation or hospitalization, foreign body sensation in the inguinal area, incision healing, infection, postoperative chronic pain, postoperative allergy, hydrocele, and orchitis, were similar between the two groups.
Conclusion: Lichtenstein hernioplasty using the SIS mesh was safe and effective, and the new SIS mesh tested in this study had comparable safety and efficacy to the wildly used SIS mesh.
Keywords: hernias, lichtenstein hernioplasty, biologic mesh
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