Randomized clinical trial comparing a polypropylene with a poliglecaprone and polypropylene composite mesh for inguinal hernioplasty

Abstract

Background The aim was to assess whether a partially absorbable monofilament mesh could influence postoperative pain and time to return to normal activity after Lichtenstein hernioplasty. Methods The study randomized patients undergoing inguinal hernia repair in 15 centres into two groups according to mesh type: lightweight (poliglecaprone–polypropylene composite) and heavyweight (polypropylene). A modified suture technique was used in the lightweight group. Follow-up on day 7 and at 3, 6 and 12 months evaluated the incidence of early and late complications, recurrence rate, quality of life, postoperative pain and return to physical activity. Results A total of 600 patients were randomized and, after monitoring visits (leading to the exclusion of seven hospitals), 392 qualified for assessment. At 12 months, the recurrence rate did not differ (1·9 versus 0·6 per cent; P = 0·493). The lightweight group reported less pain on day 7 (55·2 versus 36·2 per cent; P < 0·001) and at 3 months (17·1 versus 9·8 per cent; P = 0·033) but pain was similar for both groups at 1 year. General health and physical activity according to Short Form 36 scores increased in both groups. Conclusion Use of partially absorbable mesh reduced postoperative pain in the short term. No difference in pain or recurrence rates were observed at 12 months. Registration number: CCT-NAPN-17412 (http://www.controlled-trials.com)