Is it time for a better emergent laparotomy sunset? Prophylactic sub-lay non absorbable mesh following emergent midline laparotomy in clean and clean/contemned field: early results of a randomized double blind prospective trial.

Background: Incisional Hernia (IH) is one of the most frequent postoperative complications in abdominal surgery causing significant morbidity and even mortality. This study examines feasibility, safety and IH rate of prophylactic sub-lay mesh stripe implant of Parietex Progrip(Medtronic), in order to prevent IH following midline laparotomy in clean and clean-contaminated wound in an emergency setting. Methods: The study is a double-blind randomized trial comparing simple double-layer laparotomy closure with permanent sub-lay mesh reinforced suture. From Gennuary 2017 to June 2018, 100 Patients undergoing median laparotomy for emergency clean and clean-contaminated surgery where included and divided in two groups: primary closure (Group A) and sublay mesh supported closure (Group B). Primary endpoint was the IH rate at 1-year follow-up. Secondary endpoints were feasibility and safety of mesh stripe implantation (including postoperative pain) and morbidity/mortality rate in the two groups. Results: A total of 100 patients were included in this study. Follow-up at 1 year was available for 93 patients (Group A =47; Group B =45). IH was diagnosed in 11/46 (23%) patients of Group A and in 2/45 (4%) patients of Group B (p<0.01). In both groups, minor and major complications as well as postoperative pain are reported with no statistically significant difference between the two groups. Conclusion: Prophylactic strip mesh [Progrip Parietex (Medtronic)] abdominal wall reinforcement in retro-muscular position at the time of emergent laparotomy in clean/clean-contaminated wounds is safe. Its use may be effective to reduce IH rate, although longer term follow-up is required.背景：切口疝（Incisional Hernia, IH）是腹部手术最常见的术后并发症之一，可引发显著的发病率甚至死亡。本研究旨在评估预防性植入美敦力（Medtronic）Parietex Progrip条状筋膜下补片的可行性、安全性及切口疝发生率，以预防急诊清洁与清洁污染伤口正中剖腹术后的切口疝。 方法：本研究为双盲随机对照试验，对比单纯双层剖腹术缝合与永久性筋膜下补片增强缝合方案。2017年1月至2018年6月，共纳入100例行急诊清洁及清洁污染手术的正中剖腹术患者，随机分为两组：单纯缝合组（A组）与筋膜下补片辅助缝合组（B组）。本研究的主要终点为术后1年随访的切口疝发生率；次要终点包括条状补片植入的可行性与安全性（含术后疼痛情况）以及两组的发病率与死亡率。 结果：本研究共纳入100例患者，其中93例完成了1年随访（A组47例，B组45例）。A组11/46（23%）患者确诊切口疝，B组为2/45（4%），组间差异具有统计学意义（p<0.01）。两组的轻微与严重并发症发生率及术后疼痛均无统计学差异。 结论：在急诊清洁/清洁污染伤口剖腹术同期，于肌后位置预防性植入条状补片（美敦力Medtronic Parietex Progrip）以增强腹壁是安全的。尽管需要开展更长期的随访验证，但该方案可有效降低切口疝发生率。