Randomized trial of fascia lata and polypropylene mesh for abdominal sacrocolpopexy: 5-year follow-up.

摘要

INTRODUCTION AND HYPOTHESIS: The purpose of this study is to evaluate the 5-year surgical outcomes of abdominal sacrocolpopexy among subjects randomized to receive polypropylene mesh or cadaveric fascia lata. METHODS: All 100 subjects from the original randomized clinical trial were eligible. Primary outcome was objective anatomic failure: any pelvic organ prolapse quantification (POP-Q) point >/= - 1. Secondary outcome was clinical failure-presence of bulge or prolapse symptoms and either a POP-Q point C >/= (1/2) TVL or any POP-Q point >0-and interim surgical re-treatment. Wilcoxon tests and Fisher's exact test were performed. RESULTS: Fifty-eight subjects returned for 5-year follow-up-29 mesh and 29 fascia. Objective anatomic success rates were: mesh, 93% (27/29) and fascia, 62% (18/29) (p = 0.02). Clinical success rates were: mesh, 97% (28/29) and fascia, 90% (26/29) (p = 0.61). CONCLUSIONS: Polypropylene mesh was superior to cadaveric fascia lata using objective anatomic outcomes. Success rates of mesh and fascia were comparable using a clinical definition that combined symptoms with anatomic measures.