Early results of a single-blinded, randomized, controlled, Internet-based multicenter trial comparing Prolene and Vypro II mesh in Lichtenstein hernioplasty

Background: The standard polypropylene mesh used in Lichtenstein’s operation induces a strong foreign-tissue reaction with potentially harmful effects. A mesh with less polypropylene could possibly be beneficial. Patients and methods: Six hundred men with inguinal hernias were randomized to Lichtenstein’s operation with Prolene or Vypro II in a single-blinded multicenter trial. The randomization was performed by a computer algorithm in a database through the Internet. All data were entered and directly validated in the database through the Internet. Results  The meshes had comparable results in return to work, return to daily activities, complications, postoperative pain, and quality of life during the first 8 weeks of rehabilitation. Conclusions  Lichtenstein’s operation with either Prolene or Vypro II is safe and well tolerated with an acceptable postoperative rehabilitation time and a high quality of life 2 months after surgery. The study was facilitated by the use of a database through the Internet.