BACKGROUND: 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. STUDY DESIGN: 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.
PURPOSE:To evaluate the safety and efficacy of a new mesh in the pre-peritoneal repair of inguinal hernia.
METHODS:We randomly divided 120 patients undergoing pre-peritoneal repair into 2 groups between March 2012 and December 2013. The patients were randomized to receive the Swing mesh (n=60; study group) or the Modified Kugel mesh (n=60; control group).The primary end point of this study was to compare postoperative groin pain of the two groups. Complications, recurrence and analgesic use were also recorded.
RESULTS:There were no recurrent cases in either group throughout the study period. There was no significant difference between the groups with respect to postoperative complications. The VAS of early postoperative pain was 1.32±1.69 in study group and 1.52±1.93 in control group, with the difference being not statistically significant (p = 0.547). Concerning chronic pain, no remarkable statistically significant difference was observed between the two groups at 3-month, 6-month, 12-and 18-month follow-up period.
CONCLUSION:Swing mesh can be safely and effectively used in inguinal hernia repair with the same advantage compared to the Modified Kugel mesh.Key words: Hernia, Inguinal. Surgical Mesh.
Swing mesh versus Modified Kugel mesh for primary inguinal hernia repair. A prospective randomized clinical trial
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.