title: PREBIOUS trial: a multicenter randomized controlled trial of PREventive midline laparotomy closure with a BIOabsorbable mesh for the prevention of incisional hernia: rationale and design.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
authors.affiliation: 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.
authors.forename: Manuel
authors.initials: M
authors.lastname: López-Cano
authors.affiliation: 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. Electronic address: japerneira@gmail.com.
authors.forename: José A
authors.initials: JA
authors.lastname: Pereira
authors.affiliation: Servicio de Cirugía General y Digestiva, Hospital de Sagunto, Sagunto, Valencia, Spain. Electronic address: rlozoya@aecirujanos.es.
authors.forename: Roberto
authors.initials: R
authors.lastname: Lozoya
authors.affiliation: Servicio de Cirugía General y Digestiva, Hospital de Igualada, Igualada, Barcelona, Spain. Electronic address: 16255xfp@comb.cat.
authors.forename: Xavier
authors.initials: X
authors.lastname: Feliu
authors.affiliation: Servicio de Cirugía General y Digestiva, Hospital Universitari Arnau de Vilanova, Universitat de Lleida, Lleida, Spain. Electronic address: rafovilla26@gmail.com.
authors.forename: Rafael
authors.initials: R
authors.lastname: Villalobos
authors.affiliation: Servicio de Cirugía General y Digestiva, Hospital Universitari Parc Tauli, Universitat Autònoma de Barcelona, Sabadell, Barcelona, Spain. Electronic address: snavarro@tauli.cat.
authors.forename: Salvador
authors.initials: S
authors.lastname: Navarro
authors.affiliation: Vall d'Hebron Research Institute General and Gastrointestinal Surgery Research Group, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain. Electronic address: maarbos@gmail.com.
authors.forename: Maria Antonia
authors.initials: MA
authors.lastname: Arbós
authors.affiliation: 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: marmengol@vhebron.net.
authors.forename: Manuel
authors.initials: M
authors.lastname: Armengol-Carrasco
mesh_terms: D058107:Abdominal Wound Closure Techniques / Q000295:instrumentation*; D020341:Absorbable Implants; D015897:Comorbidity; D003362:Cost-Benefit Analysis; D005260:Female; D006304:Health Status; D046449:Hernia, Abdominal / Q000601:surgery*; D006801:Humans; D008297:Male; D016687:Polydioxanone; D011183:Postoperative Complications / Q000453:epidemiology*; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method; D013537:Sutures; D014945:Wound Healing
chemical_list: D016687:Polydioxanone
keywords: Incisional hernia; Midline laparotomy; Prevention; Prosthetic absorbable mesh; Wound closure