A prospective randomized clinical trial comparing the Prolene Hernia System® and the Lichtenstein patch technique for inguinal hernia repair in long term: 2- and 5-Year results.

BACKGROUND: Long-term sequelae in open inguinal hernia repair with either a bilayer mesh (Prolene Hernia System [PHS]) or an onlay mesh (Lichtenstein patch) were compared.
METHODS: Questionnaires, phone calls, and clinical evaluation were applied as follow-up at 2 and 5 years postoperatively.
RESULTS: Five percent of patients in the PHS group and 14% in the Lichtenstein group (P = .022) reported sensory dysfunction of the skin in the operated groin at 5 years. Chronic postoperative pain decreased over time and was reported by 11% of all patients at 5 years. Discomfort in the operated groin was found in 25% of all patients 5 years after the operation. The cumulative recurrence rate at 5 years was .8% for the PHS and 1.7% for the Lichtenstein procedure (P = .620).
CONCLUSIONS: The 2 approaches resulted in comparable rates of recurrence and long-term chronic postoperative pain. The Lichtenstein patch caused significantly more often long-term sensory dysfunction of the skin in the operated groin.

RCT Entities:   Population Interventions Outcomes