From the Department of Surgery, University of Houston, Hospital Corporation of America Kingwood, Kingwood, TX (Coelho, Ali, Liang).
Department of Surgery, McGovern Medical School at UTHealth, Houston, TX (Dhanani, Bernardi, Askenasy, Millas, Holihan).
J Am Coll Surg. 2023 Aug 1;237(2):309-317. doi: 10.1097/XCS.0000000000000705. Epub 2023 Apr 11.
Ventral incisional hernias are the most common complication after abdominal operation. Randomized trials have shown efficacy of prophylactic synthetic mesh and small bites. Adoption of these practices has been limited due to concerns with placement of synthetic mesh in contaminated cases and small bites in an overweight population. We sought to assess the efficacy of prophylactic biologic mesh and small bites to prevent postoperative major complications: ventral incisional hernias, surgical site infection, reoperation, and death.
High-risk patients (overweight/obese, current smoker) undergoing abdominal operation with a midline incision (5 cm or greater) were randomized (2 × 2 factorial trial) to receive either sublay biologic mesh or no mesh and either small bites (0.5 × 0. 5cm) or large bites (1 × 1 cm) fascial closure. The primary outcome measure was major complications at 1 year postoperative. CONSORT guidelines were followed, and this study was registered on clinicaltrials.gov (NCT03148496). Assuming α = 0.05, β = 0.20, and Δ = 20%, it was estimated that 105 patients were needed. Primary outcome was assessed using Fisher's exact test.
A total of 107 patients were randomized: 52 (49%) to mesh, 55 (51%) to no mesh, 55 (51%) to small bites, and 52 (49%) to large bites. Of the patients, 16% were smokers, 31% were overweight, and 55% were obese. At 1 year postoperative, there were no differences in major complications between groups (mesh vs no mesh 21% vs 16%, p = 0.62; small vs large bites 18% vs 19%, p = 1.00).
In this trial, biologic mesh and small bites appear to have no benefit. Further randomized trials are needed among high-risk patients before widespread adoption of prophylactic biologic mesh or small bites.
腹壁切口疝是腹部手术后最常见的并发症。随机试验已经证明了预防性合成网片和小切口的有效性。由于对合成网片在污染情况下的放置和超重人群中小切口的应用存在担忧，这些方法的应用受到了限制。我们旨在评估预防性生物网片和小切口预防术后主要并发症（腹壁切口疝、手术部位感染、再次手术和死亡）的效果。
患有肥胖/超重、当前吸烟者的高危患者（超重/肥胖、当前吸烟者）接受腹部手术（切口长度为 5cm 或更长），随机（2×2 析因试验）接受腹横筋膜下生物网片或不使用网片，以及小切口（0.5×0.5cm）或大切口（1×1cm）筋膜闭合。主要观察指标是术后 1 年的主要并发症。遵循 CONSORT 指南，并在 clinicaltrials.gov（NCT03148496）上注册了该研究。假设α=0.05，β=0.20，Δ=20%，估计需要 105 名患者。使用 Fisher 精确检验评估主要结局。
共有 107 名患者被随机分组：52 名（49%）接受网片，55 名（51%）接受无网片，55 名（51%）接受小切口，52 名（49%）接受大切口。患者中吸烟者占 16%，超重者占 31%，肥胖者占 55%。术后 1 年，两组之间主要并发症无差异（网片组 vs 无网片组 21% vs 16%，p=0.62；小切口组 vs 大切口组 18% vs 19%，p=1.00）。
在这项试验中，生物网片和小切口似乎没有益处。在广泛采用预防性生物网片或小切口之前，需要在高危患者中进行进一步的随机试验。
