Harris Hobart W, Primus Frank, Young Charlotte, Carter Jonathan T, Lin Matthew, Mukhtar Rita A, Yeh Benjamin, Allen Isabel E, Freise Chris, Kim Esther, Sbitany Hani, Young David M, Hansen Scott
Department of Surgery, University of California, San Francisco, CA.
Department of Radiology and Biomedical Imaging, University of California, San Francisco, CA.
Ann Surg. 2021 Apr 1;273(4):648-655. doi: 10.1097/SLA.0000000000004336.
The aim of this study was to evaluate which mesh type yields lower recurrence and complication rates after ventral hernia repair.
More than 400,000 ventral hernia repairs are performed annually in the United States. Although the most effective method for repairing ventral hernias involves using mesh, whether to use biologic mesh versus synthetic mesh is controversial.
Single-blind, randomized, controlled, pragmatic clinical trial conducted from March 2014 through October 2018; 165 patients enrolled with an average follow up of 26 months. Patients were randomized 1:1 to have their ventral hernias repaired using either a biologic (porcine) or synthetic (polypropylene) mesh. The primary study outcome measure was hernia recurrence at 2 years.
A total of 165 patients (68 men), mean age 55 years, were included in the study with a mean follow-up of 26 months. An intention-to-treat analysis noted that hernias recurred in 25 patients (39.7%) assigned to biologic mesh and in 14 patients (21.9%) assigned to synthetic mesh (P = 0.035) at 2 years. Subgroup analysis identified an increased rate of hernia recurrence in the biologic versus the synthetic mesh group under contaminated wound conditions (50.0% vs 5.9%; P for interaction = 0.041). Postoperative complication rates were similar for the 2 mesh types.
The risk of hernia recurrence was significantly higher for patients undergoing ventral hernia repair with biologic mesh compared to synthetic mesh, with similar rates of postoperative complications. These data indicate that the use of synthetic mesh over biologic mesh to repair ventral hernias is effective and can be endorsed, including under contaminated wound conditions.
ClinicalTrials.gov Identifier: NCT02041494.
本研究旨在评估哪种补片类型在腹疝修补术后能产生更低的复发率和并发症发生率。
在美国，每年进行超过40万例腹疝修补术。尽管修补腹疝最有效的方法是使用补片，但使用生物补片还是合成补片仍存在争议。
2014年3月至2018年10月进行的单盲、随机、对照、实用性临床试验；165例患者入组，平均随访26个月。患者按1:1随机分组，使用生物（猪源）或合成（聚丙烯）补片修补腹疝。主要研究结局指标为2年时的疝复发情况。
本研究共纳入165例患者（68例男性），平均年龄55岁，平均随访26个月。意向性分析表明，2年时，分配至生物补片组的25例患者（39.7%）疝复发，分配至合成补片组的14例患者（21.9%）疝复发（P = 0.035）。亚组分析发现，在污染伤口条件下，生物补片组的疝复发率高于合成补片组（50.0%对5.9%；交互作用P = 0.041）。两种补片类型的术后并发症发生率相似。
与合成补片相比，使用生物补片进行腹疝修补的患者疝复发风险显著更高，术后并发症发生率相似。这些数据表明，使用合成补片而非生物补片修补腹疝是有效的，并且可以得到认可，包括在污染伤口条件下。
ClinicalTrials.gov标识符：NCT02041494。
