Long-term follow-up of a randomized clinical trial of non-mesh versus mesh repair of primary inguinal hernia.

BACKGROUND: Prospective studies and meta-analyses have indicated that non-mesh repair is inferior to mesh repair based on recurrence rates in inguinal hernia. The only reliable way to evaluate recurrence rates after hernia surgery is by long-term follow-up.

METHODS: Between September 1993 and January 1996, a multicentre clinical trial was performed, in which 300 patients with unilateral primary inguinal hernia were randomized to non-mesh or mesh repair. Long-term follow-up was carried out from June 2005 to January 2006.

RESULTS: Median follow-up was 128 months for non-mesh and 129 months for mesh repair. The 10-year cumulative hernia recurrence rates were 17 and 1 per cent respectively (P = 0.005). Half of the recurrences developed after 3 years' follow-up. There was no significant correlation between hernia recurrence and age, level of expertise of the surgeon, contralateral hernia, obesity, history of pulmonary disease, constipation or prostate disease.

CONCLUSION: After 10 years mesh repair is still superior to non-mesh hernia repair. Recurrence rates may be underestimated as recurrences continue to develop for up to 10 years after surgery.