Mesh Vs RTL project

Purpose: To compare reinforced tension line (RTL) and mesh techniques in the onlay position for abdominal wound dehiscence (AWD) prevention in a noninferiority clinical trial.
Methods: Patients >18 years old who underwent midline laparotomy regardless of the background diagnosis, who were urgent or scheduled, or who were considered high risk according to a score equal to or greater than 4 on the modified Rotterdam risk scale were included. The primary outcome was the incidence of AWD within the first 30 days post-surgery, and the secondary outcome was the incidence of complications reported as surgical site occurrence (SSO).
Results: In total, 239 patients were included: 121 in the mesh group and 118 in the RTL group. Five (4.1%) of the 121 patients in the mesh group and 7 (5.9%) of the 118 patients in the RTL group presented with AWD (p= 0.56, RR=0.69, 95% CI=0.22-2.13) in the per-protocol analysis. The median time of presentation was 6 days, and all AWD patients were clinically diagnosed. The 95% CI (-0.0567, 0.0231) for the difference in incidence between the two groups was entirely within the predefined noninferiority margin of 5%. The incidence of complications was greater, but not significantly so, in the mesh group (27, 22.3%) than in the RTL group (16, 12.8%).
Conclusions: Use of the RTL technique for preventing AWD injury is not inferior to the use of mesh in the onlay position, nor does it increase the risk of complications. This study was registered on clinicaltrials.gov: Mesh-RTL Project (NCT04134455).

研究目的：在一项非劣效性临床试验中，比较强化张力线（reinforced tension line, RTL）与铺放式补片（mesh）技术在腹部切口裂开（abdominal wound dehiscence, AWD）预防中的应用效果。
研究方法：纳入年龄＞18岁、接受正中剖腹手术的患者，无论基础诊断类型；纳入人群包括急诊手术患者、择期手术患者，以及经改良鹿特丹风险量表（modified Rotterdam risk scale）评分≥4分判定为高风险的患者。本研究的主要结局指标为术后前30天内腹部切口裂开的发生率，次要结局指标为手术部位事件（surgical site occurrence, SSO）的发生率。
研究结果：共计纳入239例患者，其中补片组121例，RTL组118例。符合方案集分析显示，补片组121例患者中有5例（4.1%）发生腹部切口裂开，RTL组118例患者中有7例（5.9%）发生，组间差异无统计学意义（p=0.56，相对风险RR=0.69，95%置信区间CI=0.22~2.13）。患者出现腹部切口裂开的中位时间为6天，所有病例均经临床确诊。两组发生率差值的95%置信区间为(-0.0567, 0.0231)，完全落在预设的5%非劣效界值范围内。补片组并发症发生率为22.3%（27/121），高于RTL组的12.8%（16/118），但差异无统计学显著性。
研究结论：用于预防腹部切口裂开的RTL技术，其效果不劣于铺放位补片技术，且不会增加并发症风险。本研究已在clinicaltrials.gov注册：Mesh-RTL项目（NCT04134455）。