López-Cano Manuel, Pereira José A, Lozoya Roberto, Feliu Xavier, Villalobos Rafael, Navarro Salvador, Arbós Maria Antonia, Armengol-Carrasco Manuel
Unidad de Cirugía de la Pared Abdominal, Servicio de Cirugía General y Digestiva, Hospital Universitario Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain; Vall d'Hebron Research Institute General and Gastrointestinal Surgery Research Group, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.
Servicio de Cirugía General y Digestiva, Hospital del Mar, Parc de Salut Mar, Departamento de Ciencias Experimentales y de la Salud, Universitat Pompeu Fabra, Barcelona, Spain.
Contemp Clin Trials. 2014 Nov;39(2):335-41. doi: 10.1016/j.cct.2014.10.009. Epub 2014 Nov 1.
Development of an incisional hernia is one of the most frequent complications of midline laparotomies requiring reoperation. This paper presents the rationale, design, and study protocol for a randomized controlled trial, the aim of which is to evaluate the efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for reinforcement of a midline fascial closure.
The PREBIOUS trial (PREventive midline laparotomy closure with a BIOabsorbable mesh) is a multicenter randomized controlled trial in which adult patients undergoing elective or urgent open abdominal operations through a midline laparotomy incision are assigned to one of two groups based on the laparotomy closure procedure: an intervention group in which a continuous polydioxanone (PDS) suture is reinforced with a commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W.L. Gore & Associates, Flagstaff, AZ, USA), or a control group with continuous PDS suture only. Both groups are followed over 6 months.
The primary outcome is the appearance of incisional hernias assessed by physical examination at clinical visits and radiologically (CT scan) performed at the end of follow-up. Secondary outcomes are the rate of complications, mainly infection, hematoma, burst abdomen, pain, and reoperation. The PREBIOUS trial has the potential to demonstrate that suture plus prosthetic mesh insertion for routine midline laparotomy closure is effective in preventing incisional hernias after open abdominal surgery, to avoid the effects on those affected, such as poor cosmesis, social embarrassment, or impaired quality of life, and to save costs potentially associated with incisional hernia surgical repair.
切口疝的发生是需要再次手术的中线剖腹手术最常见的并发症之一。本文介绍了一项随机对照试验的基本原理、设计和研究方案，其目的是评估预防性放置生物可吸收合成补片加强中线筋膜缝合的有效性和安全性。
PREBIOUS试验（使用生物可吸收补片预防中线剖腹手术闭合）是一项多中心随机对照试验，在该试验中，通过中线剖腹手术切口接受择期或急诊开腹手术的成年患者根据剖腹手术闭合程序被分配到两组之一：干预组，使用市售的戈尔® BIO - A® 组织加强假体（美国亚利桑那州弗拉格斯塔夫的W.L.戈尔公司）加强连续聚二氧六环酮（PDS）缝合，或仅使用连续PDS缝合的对照组。两组均随访6个月。
主要结果是通过临床就诊时的体格检查和随访结束时进行的放射学检查（CT扫描）评估切口疝的出现情况。次要结果是并发症发生率，主要是感染、血肿、腹壁裂开、疼痛和再次手术。PREBIOUS试验有可能证明，在常规中线剖腹手术闭合中使用缝合加假体补片插入可有效预防开腹手术后的切口疝，避免对患者造成诸如美观不佳、社交尴尬或生活质量受损等影响，并节省与切口疝手术修复可能相关的成本。
