title: Biological Mesh Closure of the Pelvic Floor After Extralevator Abdominoperineal Resection for Rectal Cancer: A Multicenter Randomized Controlled Trial (the BIOPEX-study).
abstract: To determine the effect of biological mesh closure on perineal wound healing after extralevator abdominoperineal resection (eAPR).
  
  
  
  Perineal wound complications frequently occur after eAPR with preoperative radiotherapy for rectal cancer. Cohort studies have suggested that biological mesh closure of the pelvic floor improves perineal wound healing.
  
  
  
  Patients were randomly assigned to primary closure (standard arm) or biological mesh closure (intervention arm). A non-cross-linked porcine acellular dermal mesh was sutured to the pelvic floor remnants in the intervention arm, followed by a layered closure of the ischioanal and subcutaneous fat and skin similar to the control intervention. The outcome of the randomization was concealed from the patient and perineal wound assessor. The primary endpoint was the rate of uncomplicated perineal wound healing defined as a Southampton wound score of less than 2 at 30 days postoperatively. Patients were followed for 1 year.
  
  
  
  In total, 104 patients were randomly assigned to primary closure (n = 54; 1 dropouts) and biological mesh closure (n = 50; 2 dropouts). Uncomplicated perineal wound healing rate at 30 days was 66% (33/50; 3 not evaluable) after primary closure, which did not significantly differ from 63% (30/48) after biological mesh closure [relative risk 1.056; 95% confidence interval (CI) 0.7854-1.4197; P = 0.7177). Freedom from perineal hernia at 1 year was 73% (95% CI 60.93-85.07) versus 87% (95% CI 77.49-96.51), respectively (P = 0.0316).
  
  
  
  Perineal wound healing after eAPR with preoperative radiotherapy for rectal cancer was not improved when using a biological mesh. A significantly lower 1-year perineal hernia rate after biological mesh closure is a promising secondary finding that needs longer follow-up to determine its clinical relevance.
authors: *Department of Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands †Department of Surgery, Deventer Hospital, Deventer, The Netherlands ‡Department of Surgery, Erasmus Medical Center/Daniel den Hoed, Rotterdam, The Netherlands §Department of Surgery, Gelre Hospital, Apeldoorn, The Netherlands ¶Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands ||Department of Surgery, Tergooi Hospital, Hilversum, The Netherlands **Department of Surgery, IJsselland Hospital, Capelle aan de IJssel, The Netherlands ††Department of Surgery, Medical Center Leeuwarden, Leeuwarden, The Netherlands ‡‡Department of Surgery, St. Laurentius Hospital, Roermond, The Netherlands §§Department of Surgery, School of Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands ¶¶GROW: School of Oncology and Developmental Biology, Maastricht, The Netherlands ||||Department of Surgery, University Hospitals Leicester, Leicester, UK ***Department of Surgery, Spaarne Gasthuis, Haarlem, The Netherlands †††Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands ‡‡‡Clinical Research Unit, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
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mesh_terms: D000005:Abdomen / Q000601:surgery; D062088:Acellular Dermis; D000368:Aged; D000818:Animals; D005260:Female; D006547:Hernia / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D017773:Pelvic Floor / Q000601:surgery*; D010502:Perineum / Q000502:physiology / Q000601:surgery*; D011183:Postoperative Complications / Q000517:prevention & control; D011446:Prospective Studies; D011788:Quality of Life; D018714:Radiotherapy, Adjuvant; D012004:Rectal Neoplasms / Q000532:radiotherapy / Q000601:surgery*; D016037:Single-Blind Method; D013526:Surgical Mesh; D013530:Surgical Wound Infection / Q000517:prevention & control; D013552:Swine; D014945:Wound Healing