Results of a prospective multicenter trial evaluating the ePTFE peritoneal onlay laparoscopic inguinal hernioplasty.

A 2.8-year prospective multicenter trial was conducted to evaluate the ePTFE peritoneal onlay laparoscopic inguinal hernioplasty. A total of 441 inguinal hernias were repaired in 351 patients (326 male; 25 female). Two hundred twenty-six of the hernias were direct, 185 indirect, 4 femoral, 26 pantaloon, 90 bilateral, and 92 recurrent. Standardized data collection forms were used and submitted for centralized data analysis. For the hernioplasty, Cooper's ligament was exposed and an 8 cm x 12 cm x 1 mm GORE-TEX Soft Tissue Patch was stapled circumferentially to Cooper's ligament and the endoabdominal fascia. Patients were followed at 1 week, 6 months, 1 year, and then annually. Three-month intervals were used as needed. There was a mean follow-up of 447 days, with 21% of the total repairs followed for more than 2 years and 56% for more than a year. The overall follow-up rate was 95.5%. The operative and postoperative complication rates were 0.45% and 8%, respectively. There were 17 recurrent hernias (3.8%). The range of experience among the investigators was 13 to 168 hernioplasties. With the completion of 25 cases per investigator, the recurrence rate fell to 0.39%. Postoperative analgesia averaged a 24-hr supply of medication; 12.2% of patients required no analgesia. Convalescence averaged 5.4 days, and return to work averaged 7.7 days. This multicenter trial demonstrates that the ePTFE laparoscopic peritoneal onlay inguinal hernioplasty is a safe and dependable repair, especially after the initial learning curve is surmounted.