Document Detail


Porcine dermis compared with polypropylene mesh for laparoscopic sacrocolpopexy: a randomized controlled trial.
MedLine Citation:
PMID:  23262939     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
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.
CLINICAL TRIAL REGISTRATION: : ClinicalTrials.gov, www.clinicaltrials.gov, NCT00564083.
LEVEL OF EVIDENCE: : I.
Authors:
Patrick J Culligan; Charbel Salamon; Jennifer L Priestley; Amir Shariati
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Obstetrics and gynecology     Volume:  121     ISSN:  1873-233X     ISO Abbreviation:  Obstet Gynecol     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2012-12-24     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0401101     Medline TA:  Obstet Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  143-51     Citation Subset:  AIM; IM    
Affiliation:
Division of Urogynecology, Atlantic Health System, Morristown New Jersey; Department of Obstetrics, Gynecology and Reproductive Science, Mount Sinai School of Medicine, New York, New York; and Department of Mathematics and Statistics, Kennesaw State University, Kennesaw, Georgia.
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