Interim analysis of single - centre randomised controlled trial on incisional hernia repair with vs without synthetic mesh fixation.

Abstract

Introduction: In a prospective randomised trial, we aimed to compare incisional hernia repair with mesh fixation versus incisional hernia repair without mesh fixation.

Methods: The study was performed from June 2018 to August 2024 at a single centre in Vilnius, Lithuania. Fifty-seven patients with incisional abdominal wall hernia were randomly included into two groups: group one-"sublay" hernia repair with mesh fixation and the second - without mesh fixation. The duration of surgery, hospital stay, pain levels, quality of life and rate of complications were compared.

Results: Of the 38 women and 19 men who were included in the study, 30 were with mesh fixation and 27 without mesh fixation. The median patient's body mass index was 31.57 ± 5.96 (19.5-49.6). The most common hernia width was W2 according to the European Hernia Society (EHS) classification. A significant difference between the groups was found in duration of surgery - 108.00 ± 47.35 (40-235) minutes in the mesh fixation group vs. 75.74 ± 30.25 (35-150)-without the mesh fixation group (p < 0.05). A higher pain level was observed on the 10th postoperative day-3.03 ± 2.54 in the mesh fixation group versus 1.67 ± 2.22 in the group without the mesh fixation group (p < 0.05). A statistically significant difference was also observed in seroma rate after 6 months (16.6% versus 0%, p < 0.05). There have been no hernia recurrences in either group so far.

Conclusions: No mesh fixation on "sublay" hernia repair does not worsen the patient's postoperative condition. It does not increase postoperative pain, worsen the quality of life, or increase the risk of postoperative complications. On the 10th postoperative day, the non-fixed mesh group had less postoperative pain, however, later the pain was equal. A lower number of seromas was also observed in this group after 6 months. However, the operative time in the group without mesh fixation was significantly shorter.