Comparison of self-fixating mesh to tack fixation in laparoscopic inguinal hernia repair: a double-blind randomized clinical trial (SELFITAC).

purposeTo compare postoperative pain, hernia-specific Quality of Life, inflammatory response and the long-term hernia-related complaints between self-fixating mesh and limited tack fixation in laparoscopic totally extraperitoneal (TEP) inguinal hernia repair.

methodsThis prospective double-blind randomised clinical trial enrolled adult males undergoing elective unilateral TEP repair between April 2018 and December 2020. The patients were randomised in a 1:1 ratio to receive either self-fixating mesh (n = 56) or limited mesh fixation with up to three non-absorbable tacks (n = 56). The primary outcomes studied were postoperative pain (Visual Analogue Scale, VAS) and Quality of Life (Carolina Comfort Scale, CCS), recorded at prespecified intervals up to 3 months. The secondary outcomes included operative time, mesh deployment time, complications, analgesic consumption, length of stay, inflammatory markers (WBC at 48 h; ESR at 3 months) and a predefined long-term follow-up to evaluate late pain, hernia-related discomfort, recurrence, contralateral hernia development, and chronic pain outcomes after at least 5 years of the index surgery.

resultsThe operative duration and mesh deployment times were similar in both groups. Mesh deployment time was initially longer with self-fixating mesh in the first chronological quartile, but progressively decreased with experience and was comparable to tack fixation by later quartiles, demonstrating a significant learning-curve effect. Median VAS and CCS scores at all prespecified time points showed no clinically meaningful difference. Analgesic requirements were comparable between groups. Both groups demonstrated a significant postoperative rise in inflammatory markers; however, the magnitude of change was lower in the self-fixating mesh group, with statistically significant differences between groups in ΔWBC and ΔESR. Cord oedema and seroma were the most frequent postoperative surgical site occurrences (SSOs), with similar rates in either group. Only 96 of the 112 patients could be followed up after at least 5 years of the index surgery with an average of 78.5 months follow up. Both groups demonstrated minimal pain and mesh-related discomfort, with no clinically meaningful differences in average VAS or Carolina Comfort Scale scores. The rates of chronic pain (VAS ≥ 3) were low (four in each arm) and comparable between groups. No significant difference was observed in long-term pain-related functional impairment. One recurrence was detected in the self-fixating arm during the study.

conclusionThe postoperative pain scores, hernia-specific quality-of-life outcomes, and early and late complication rates, including recurrence, with the use of self-fixating mesh were comparable to those observed with limited tack fixation in TEP repair. Although inflammatory markers increased postoperatively in both groups, the magnitude of the inflammatory response was modestly lower in the self-fixating mesh group. Mesh deployment time was initially longer with self-fixating mesh but decreased significantly with experience and became comparable to tack fixation, indicating a short and clinically acceptable learning curve. These findings support self-fixating mesh as a safe and atraumatic alternative fixation strategy in TEP repair with comparable short-term and long-term pain, quality of life, and recurrence rates.