Multicentric pragmatic randomized controlled trial of mesh fixation system in primary and recurrent ventral hernia repair.

Abstract

Controversy persists regarding the ideal type of fixation for hernia mesh. Transfixing methods have been linked to tissue trauma and to the development of chronic pain. In ventral hernia repair (VHR), retrospective studies showed a potential for fixation with cyanoacrylate of being as effective as conventional suture or tacks methods but with less postoperative pain and complications. A pragmatic randomized trial was conducted on patients undergoing primary and incisional VHR, analyzing mesh fixation by cyanoacrylate (experimental group) versus sutures or reabsorbable tacks (control group), stratifying a priori by laparoscopic(LVHR) and open approach(OVHR) to account for distinct anatomical and biomechanical environments. Primary outcome was chronic postoperative pain. Secondary outcomes were postoperative complications, recurrence, operating time, intraoperative blood loss, pain during admission. Univariable and multivariable analysis were conducted. Two hundred fourteen patients were included, of which 109 treated laparoscopically. Overall chronic pain occurred exclusively within the open surgery cohort (12/105 cases, 11.4%), with no statistical difference between fixation arms. Cyanoacrylate for mesh fixation was independent factor for fewer perioperative complications (OR 0.457, 95% CI 0.244-0.855, p = 0.014), shorter operating time (- 7.172 min, 95%CI - 23.040/- 2.008, p = 0.02), reduced pain at hospital discharge (- 0.356 VAS point, 95%CI - 0.691/- 0.022, p = 0.037). In LVHR, non-transfixing mesh positioning was also a factor for less intraoperative blood loss. In OVHR there were no significant difference in outcomes between groups. In a pragmatic real-world setting, long-term chronic pain appears primarily driven by surgical access and wound-related factors rather than the independent effect of the mesh fixation method. Cyanoacrylate fixation provides significant perioperative advantages, particularly in LVHR.