A Prospective Randomized Trial Comparing the Rebound Hernia Repair Device and Lightweight Mesh for Laparoscopic Inguinal Hernia: an Interim Analysis

John S Roth, MD, Jeff Hazey, MD, Daniel Davenport, PhD, Vimal Narula, MD, Rebecca Dettorre, MD, Ambar Banarjee, MD, William Cavatassi, MD, Emily Albright, MD. Univerisity of Kentucky, Ohio State University

Background: Laparoscopic inguinal hernia repair requires placement of a synthetic mesh in the properitoneal space. Fixation of the mesh to the abdominal wall with tacks is frequently performed to facilitate mesh placement and prevent mesh migration. The Rebound Hernia Repair Device (ReboundHRD) is a lightweight polypropylene mesh with a Nitinol frame that may be utilized in laparoscopic hernia repair and does not require fixation with tacks. This study compares the early results of laparoscopic inguinal hernia repair with the ReboundHRD and the same lightweight polypropylene mesh without the Nitinol frame (LWM).

Methods: A multicenter prospective randomized trial of laparoscopic inguinal hernia repair with Rebound HRD and lightweight polypropylene mesh was performed. Randomization occurred in a 2:1 ratio (ReboundHRD:LWMesh). Preoperative demographic information, health questionaires, pain scales and quality of life information was obtained. Operative details and times were recorded. Postoperative questionaires, pain scales, and blinded physical examinations were performed.

Results: 19 patients underwent hernia repair (13ReboundHRD, 6LWM). Bilateral hernias were repaired in 62% ReboundHRD and 33%LWM. Mesh fixation with tacks was utilized in 8% Rebound HRD and 100% LWM. There were no differences in patient age (48±10 vs. 45±18, p=.64), BMI ( 25±3.2 vs 24±1.5 , p=0.49), preoperative working status (77% vs. 67%), or preoperative pain scales (15±17 mm. vs. 34±32mm , p=.10). Total OR time was similar (55±19min. vs. 62±26min, p=0.51). Operative time per side was not signficantly different (38±16 min. vs. 52±32 min, p= 0.21). Total mesh Deployment time was reduced with ReboundHRD (6±2.7min. vs. 11±4.0 min, p=.005). Mesh deployment time per side was reduced with Rebound HRD (4.3±2.7min vs. 8.3±3.1min, p=.011). Postop pain at 7 days was similar (17±16mm vs. 21±28mm, p=.69). There were no infections, Seromas occurred in 3 Rebound HRD and 1 LWM, p=1.0. There were no differences in postoperative tenderness (0 vs. 1, NS), induration (0 vs. 0, NS) and return to work at 7 days (70% vs. 100%, p=.51).

Conclusions: Laparoscopic Inguinal Hernia Repair with the Rebound HRD reduces mesh deployment time. Short term outcomes following hernia repair are similar between Rebound HRD and lightweight mesh with tack fixation. Long term follow up to two years is ongoing.

Session: Poster
Program Number: P330
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