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

ABSTRACT

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.