Porcine dermis compared with polypropylene mesh for laparoscopic sacrocolpopexy

A randomized controlled trial

Patrick J. Culligan, Charbel Salamon, Jennifer L. Priestley, Amir Shariati

Research output: Contribution to journalArticle

19 Citations (Scopus)

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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00564083. LEVEL OF EVIDENCE: I

Original languageEnglish (US)
Pages (from-to)143-151
Number of pages9
JournalObstetrics and Gynecology
Volume121
Issue number1
DOIs
StatePublished - Jan 1 2013
Externally publishedYes

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Polypropylenes
Dermis
Pelvic Floor
Swine
Randomized Controlled Trials
Pelvic Organ Prolapse
Prolapse
Equipment and Supplies
Reoperation
Sample Size
Nurses
Clinical Trials
Research
Surveys and Questionnaires

All Science Journal Classification (ASJC) codes

  • Obstetrics and Gynecology

Cite this

Culligan, Patrick J. ; Salamon, Charbel ; Priestley, Jennifer L. ; Shariati, Amir. / Porcine dermis compared with polypropylene mesh for laparoscopic sacrocolpopexy : A randomized controlled trial. In: Obstetrics and Gynecology. 2013 ; Vol. 121, No. 1. pp. 143-151.
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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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00564083. LEVEL OF EVIDENCE: I",
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Porcine dermis compared with polypropylene mesh for laparoscopic sacrocolpopexy : A randomized controlled trial. / Culligan, Patrick J.; Salamon, Charbel; Priestley, Jennifer L.; Shariati, Amir.

In: Obstetrics and Gynecology, Vol. 121, No. 1, 01.01.2013, p. 143-151.

Research output: Contribution to journalArticle

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T1 - Porcine dermis compared with polypropylene mesh for laparoscopic sacrocolpopexy

T2 - A randomized controlled trial

AU - Culligan, Patrick J.

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N2 - 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

AB - 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

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