Lindmark Mikael, Tall Jael, Darkahi Bahman, Österberg Johanna, Strigård Karin, Thorell Anders, Gunnarsson Ulf
Department of Diagnostic and Intervention, Umeå University, Umeå, Sweden.
Skellefteå Research Unit, Skellefteå, Sweden.
Br J Surg. 2025 Sep 2;112(9). doi: 10.1093/bjs/znaf169.
Laparoscopic intraperitoneal onlay mesh repair using a bridging technique has shown high rates of hernia site complications. Primary fascial closure before mesh placement has been utilized to address this. This randomized, parallel, double-blind, multicentre controlled trial investigated whether primary fascial closure reduces hernia site complications.
Adults undergoing laparoscopic intraperitoneal onlay mesh repair for a midline hernia were randomized to primary fascial closure or bridging. Clinical assessment and the Ventral Hernia Pain Questionnaire were completed preoperatively and at 3 and 12 months post-surgery. CT scans were performed pre- and 12 months post-surgery. It was hypothesized that non-resorbable suture closure would reduce complication rates from 30% to 13% at 12 months, requiring 180 patients for 80% power and 95% significance.
One hundred and ninety-two patients were randomized (97 closure, 95 bridging), with 173 (90%) completing 1-year follow-up. At 12 months, overall hernia site complication rates showed no significant difference clinically (18% versus 20%, P = 0.85) or on CT (25% versus 28%, P = 0.50). However, recurrence and mesh bulging were significantly lower with fascial closure (4% versus 20%, P = 0.006). This group also reported significantly less pain at 12 months.
Although there was no difference in the primary endpoint, fascial closure resulted in significantly lower rates of recurrence and mesh bulging, along with reduced postoperative pain. These findings suggest that primary fascial closure should be recommended alongside intraperitoneal onlay mesh repair in midline hernias.
The trial was registered at the ISRCTN at the start of the trial (ISRCTN51495042).
采用桥接技术的腹腔镜腹膜内补片修补术已显示出较高的疝部位并发症发生率。在放置补片前进行一期筋膜缝合已被用于解决这一问题。这项随机、平行、双盲、多中心对照试验研究了一期筋膜缝合是否能降低疝部位并发症。
接受腹腔镜腹膜内补片修补中线疝的成年人被随机分为一期筋膜缝合组或桥接组。术前以及术后3个月和12个月完成临床评估和腹疝疼痛问卷。术前和术后12个月进行CT扫描。假设不可吸收缝线缝合可将12个月时的并发症发生率从30%降至13%，需要180名患者才能达到80%的检验效能和95%的显著性水平。
192名患者被随机分组（97名缝合组，95名桥接组），173名（90%）完成了1年随访。在12个月时，总体疝部位并发症发生率在临床（18%对20%，P = 0.85）或CT检查中（25%对28%，P = 0.50）均无显著差异。然而，筋膜缝合组的复发和补片膨出明显更低（4%对20%，P = 0.006）。该组在12个月时报告的疼痛也明显更少。
虽然主要终点无差异，但筋膜缝合导致复发和补片膨出率显著降低，同时术后疼痛减轻。这些发现表明，在中线疝的腹膜内补片修补术中应推荐一期筋膜缝合。
该试验在试验开始时在国际标准随机对照试验编号注册库注册（ISRCTN51495042）。
