A Randomized Trial of Low-Cost Mesh in Groin Hernia Repair

N Engl J Med. 2016 Jan 14;374(2):146-53. doi: 10.1056/NEJMoa1505126.

Abstract

Background: The most effective method for repair of a groin hernia involves the use of a synthetic mesh, but this type of mesh is unaffordable for many patients in low- and middle-income countries. Sterilized mosquito meshes have been used as a lower-cost alternative but have not been rigorously studied.

Methods: We performed a double-blind, randomized, controlled trial comparing low-cost mesh with commercial mesh (both lightweight) for the repair of a groin hernia in adult men in eastern Uganda who had primary, unilateral, reducible groin hernias. Surgery was performed by four qualified surgeons. The primary outcomes were hernia recurrence at 1 year and postoperative complications.

Results: A total of 302 patients were included in the study. The follow-up rate was 97.3% after 2 weeks and 95.6% after 1 year. Hernia recurred in 1 patient (0.7%) assigned to the low-cost mesh and in no patients assigned to the commercial mesh (absolute risk difference, 0.7 percentage points; 95% confidence interval [CI], -1.2 to 2.6; P=1.0). Postoperative complications occurred in 44 patients (30.8%) assigned to the low-cost mesh and in 44 patients (29.7%) assigned to the commercial mesh (absolute risk difference, 1.0 percentage point; 95% CI, -9.5 to 11.6; P=1.0).

Conclusions: Rates of hernia recurrence and postoperative complications did not differ significantly between men undergoing hernia repair with low-cost mesh and those undergoing hernia repair with commercial mesh. (Funded by the Swedish Research Council and others; Current Controlled Trials number, ISRCTN20596933.).

Publication types

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

MeSH terms

  • Adult
  • Developing Countries
  • Double-Blind Method
  • Follow-Up Studies
  • Hernia, Inguinal / surgery*
  • Herniorrhaphy / economics
  • Herniorrhaphy / instrumentation*
  • Humans
  • Male
  • Middle Aged
  • Patient Satisfaction
  • Postoperative Complications / epidemiology
  • Recurrence
  • Surgical Mesh / economics*
  • Uganda

Associated data

  • ISRCTN/ISRCTN20596933