• Manuel López-Cano, José A Pereira, Roberto Lozoya, Xavier Feliu, Rafael Villalobos, Salvador Navarro, Maria Antonia Arbós, and Manuel Armengol-Carrasco.
• 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. Electronic address: mlpezcano@gmail.com.
• Contemp Clin Trials. 2014 Nov 1;39(2):335-41.

BackgroundDevelopment 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.MethodsThe 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.OutcomesThe 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.Copyright © 2014 Elsevier Inc. All rights reserved.

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