Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.
Center for Surgical Trials and Evidence-Based Practice, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.
Surg Infect (Larchmt). 2021 Jun;22(5):496-503. doi: 10.1089/sur.2020.166. Epub 2020 Dec 1.
Many surgeons utilize biologic mesh for elective complex ventral hernia repair (VHR; large hernias, contaminated fields, or patients with comorbid conditions). However, no randomized controlled trials (RCTs) have compared biologic and synthetic mesh. We hypothesize biologic mesh would result in fewer major complications at one-year post-operative compared with synthetic mesh. We performed a single-center, pilot RCT. All eligible patients undergoing complex, open VHR were randomly assigned to receive biologic or synthetic mesh placed in the retromuscular position. Primary outcome was major complications, namely, a composite of mesh infection, recurrence, or re-operation at one-year post-operative. Secondary outcomes included surgical site infections (SSI), seromas, hematomas, wound dehiscence, re-admissions, and Clavien-Dindo complication grade. Outcomes were assessed using Fisher exact test and Bayesian generalized linear models. Of 87 patients, 44 were randomly assigned to biologic mesh and 43 to synthetic mesh. Most cases were wound class 2-4 (68%) and 75% had a hernia width >4 cm. Most patients were obese (70%) and had an American Society of Anesthesiogists (ASA) score of 3-4 (53%). Compared with patients in the synthetic mesh group, patients in the biologic mesh group had a higher percentage of: major complications at one-year post-operative (42.4% vs. 21.6%; relative risk [RR] = 1.96 [95% confidence interval {CI} = 0.94-4.08]; number needed to harm = 4.8; p = 0.071); SSI (15.9% vs. 9.3%; RR = 1.71 [95% CI = 0.54-5.42]; p = 0.362); wound dehiscence (25.0% vs. 14.0%; RR = 1.79 [95% CI = 0.73-4.41]; p = 0.205); and re-admissions (22.7% vs 9.3%; RR = 2.44 [95% CI = 0.83-7.20]; p = 0.105). Bayesian analysis demonstrated that compared with synthetic mesh, biologic mesh had a 95% probability of increased risk of major complications at one-year post-operative. No clear evidence of a difference was found on seromas, hematomas, or Clavien-Dindo complication grade. In elective complex open VHR, biologic mesh demonstrated no benefit compared with synthetic mesh in one-year outcomes. Moreover, Bayesian analysis suggests that biologic mesh may have an increased probability of major complications.
许多外科医生在择期复杂的腹疝修补术（VHR；大疝、污染区域或合并症患者）中使用生物补片。然而，尚无随机对照试验（RCT）比较生物补片和合成补片。我们假设生物补片在术后一年时比合成补片导致更少的主要并发症。我们进行了一项单中心、试点 RCT。所有符合条件的接受复杂、开放性 VHR 的患者被随机分配接受生物补片或合成补片置于肌后位置。主要结局是术后一年时的主要并发症，即复合感染、复发或再次手术。次要结局包括手术部位感染（SSI）、血清肿、血肿、伤口裂开、再入院和 Clavien-Dindo 并发症分级。使用 Fisher 精确检验和贝叶斯广义线性模型评估结局。87 例患者中，44 例随机分配至生物补片组，43 例随机分配至合成补片组。大多数病例为伤口 2-4 级（68%），75%的疝宽>4cm。大多数患者肥胖（70%），美国麻醉医师协会（ASA）评分 3-4 级（53%）。与合成补片组患者相比，生物补片组患者：术后一年时主要并发症发生率更高（42.4% vs. 21.6%；相对风险 [RR] 1.96 [95%置信区间 {CI} 0.94-4.08]；需要治疗的人数 [NNT] 4.8；p=0.071）；SSI（15.9% vs. 9.3%；RR 1.71 [95% CI 0.54-5.42]；p=0.362）；伤口裂开（25.0% vs. 14.0%；RR 1.79 [95% CI 0.73-4.41]；p=0.205）；再入院（22.7% vs. 9.3%；RR 2.44 [95% CI 0.83-7.20]；p=0.105）。贝叶斯分析表明，与合成补片相比，生物补片在术后一年时主要并发症风险增加的概率为 95%。在血清肿、血肿或 Clavien-Dindo 并发症分级方面，没有明显证据表明存在差异。在择期复杂的开放性 VHR 中，生物补片与合成补片相比，在一年的结局方面没有优势。此外，贝叶斯分析表明，生物补片可能更有可能发生主要并发症。
