Early results of a randomized multicenter trial comparing Prolene and VyproII mesh in bilateral endoscopic extraperitoneal hernioplast (TEP)

Background: The use of mesh in inguinal hernia surgery has become increasingly popular despite the potentially harmful effects that foreign material may exert on human tissue. The purpose of this study was to compare the use of a lightweight mesh vs a standard hernia mesh in bilateral endoscopic hernioplasty. Methods: This single-blinded multicenter trial, 140 men with bilateral inguinal hernias were randomized to undergo totally extraperitoneal endoscopic hernioplasty (TEP) with either Prolene or VyproII. The randomization and all data management were done via the Internet. Results: A total of 139 patients were operated on as allocated. The follow-up was complete in 94% of the patients. The median (range) operating times were 85 min (45-140) and 73min (35-165) for the Prolene and VyproII groups, respectively. (p = 0.01). The difference was due to uneven distribution of the allocated patients to study groups among individual surgeons. The time to return to work was similar (11 vs 9 days, p = 0.08). The time to return to normal daily activities was 19 days (1-133) in the Prolene group and 12.5 days (0-237) in the VyproII group (p = 0.06). There were no significant differences between the groups in their scores on the Visual Analogue Scale or SF-36 Health Scores during the 8-week follow-up. Conclusions: The use of Prolene and VyproII meshes in bilateral endoscopic repair of inguinal hernia seems to result in similar short-term outcome and quality of life. However, there was a tendency toward faster return to normal activity among VyproII patients.