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

Hernia. 2004 May;8(2):127-34. doi: 10.1007/s10029-003-0192-3. Epub 2003 Nov 26.

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Hernia, Inguinal / surgery*
  • Humans
  • Internet
  • Male
  • Middle Aged
  • Polyglactin 910*
  • Polypropylenes*
  • Postoperative Complications
  • Quality of Life
  • Randomized Controlled Trials as Topic / methods
  • Single-Blind Method
  • Surgical Mesh*

Substances

  • Polypropylenes
  • Polyglactin 910