title: Porcine dermis compared with polypropylene mesh for laparoscopic sacrocolpopexy: a randomized controlled trial.
abstract: OBJECTIVE
  To compare the surgical outcomes 12 months after laparoscopic sacrocolpopexy performed with porcine dermis and the current gold standard of polypropylene mesh.
  
  
  METHODS
  Patients scheduled for laparoscopic sacrocolpopexy were eligible for this randomized controlled trial. Both our clinical research nurse and the patients were blinded as to which material was used. Our primary end point was objective anatomic cure defined as no pelvic organ prolapse quantification (POP-Q) points Stage 2 or greater at any postoperative interval. Our sample size calculation called for 57 patients in each group to achieve 90% power to detect a 23% difference in objective anatomic cure at 12 months (α=0.05). Our secondary end point was clinical cure. Any patient with a POP-Q point greater than zero, or Point C less than or equal to -5, or any complaints of prolapse symptoms whatsoever on Pelvic Floor Distress Inventory-20 or Pelvic Floor Impact Questionnaire, Short Form 7, or reoperation for prolapse were considered "clinical failures"; the rest were "clinical cures." Statistical comparisons were performed using the χ or independent samples t test as appropriate.
  
  
  RESULTS
  As expected, there were no preoperative differences between the porcine (n=57) and mesh (n=58) groups. The 12-month objective anatomic cure rates for the porcine and mesh groups were 80.7% and 86.2%, respectively (P=.24), and the "clinical cure" rates for the porcine and mesh groups were 84.2% and 89.7%, respectively (P=.96). Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire, Short Form 7 score improvements were significant for both groups with no differences found between groups. There were no major operative complications.
  
  
  CONCLUSIONS
  There were similar outcomes in subjective or objective results 12 months after laparoscopic sacrocolpopexy performed with either porcine dermis or polypropylene mesh.
  
  
  BACKGROUND
  ClinicalTrials.gov, www.clinicaltrials.gov, NCT00564083.
  
  
  METHODS
  I.
authors.affiliation: Division of Urogynecology, Atlantic Health System, Morristown New Jersey, USA. patrick.culligan@atlantichealth.org
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Culligan
authors.forename: Charbel
authors.initials: C
authors.lastname: Salamon
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Priestley
authors.forename: Amir
authors.initials: A
authors.lastname: Shariati
mesh_terms: D000368:Aged; D000818:Animals; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000379:methods*; D006801:Humans; D010535:Laparoscopy / Q000379:methods*; D008875:Middle Aged; D017060:Patient Satisfaction; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D011126:Polypropylenes / Q000627:therapeutic use*; D016038:Skin Transplantation; D013526:Surgical Mesh; D011795:Surveys and Questionnaires; D013552:Swine; D014183:Transplantation, Heterologous; D016896:Treatment Outcome
chemical_list: D011126:Polypropylenes