Edward Morcos1, Daniel Altman2,3, Daniel Hunde2, Christian Falconer2. 1. Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet Danderyd University Hospital, 182 88 Danderyd, Stockholm, Sweden. edward.morcos@sll.se. 2. Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet Danderyd University Hospital, 182 88 Danderyd, Stockholm, Sweden. 3. Stockholm Urogynecological Clinic, Kommendörsgatan 5, 11448, Stockholm, Sweden.
Abstract
INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the results of pelvic organ prolapse repair using a capturing device-guided transvaginal mesh in a single- vs multicenter setting. METHODS: One hundred and twelve women operated by two surgeons at one center (2-year follow-up) were compared with 207 women operated on by 26 surgeons at 24 centers (1-year follow-up). Patients were screened at baseline for apical (uterine or vaginal vault) prolapse stage II with or without concomitant anterior vaginal wall prolapse ≥ stage 2 according to the pelvic organ prolapse quantification (POP-Q) system. Outcome measurements included POP-Q evaluations, prolapse-specific symptom questionnaires, and surgical data. RESULTS: At the end of follow-up 95 out of 98 (96.9%) had an optimal anatomical outcome at the apical segment (POP-Q stage 0-1) in the single center compared with 154 out of 164 (93.9%) in the multicenter study (P = 0.03). There were no serious complications in the single-center study compared with 9 out of 207 (4.3%) in the multicenter study. In patients undergoing surgery for recurrence, the risk ratio for complications overall was 4:1 in favor of the single-center study. There were no significant differences between the studies in any subjective symptom scale. CONCLUSIONS: Compared with multicenter use, large volumes at a single site only resulted in minor improvements of anatomical outcomes and no significant differences with regard to patient-reported outcomes on pelvic organ function or related quality of life. Instead, the greatest benefit of single-center use was the significantly decreased complication rates.
INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the results of pelvic organ prolapse repair using a capturing device-guided transvaginal mesh in a single- vs multicenter setting. METHODS: One hundred and twelve women operated by two surgeons at one center (2-year follow-up) were compared with 207 women operated on by 26 surgeons at 24 centers (1-year follow-up). Patients were screened at baseline for apical (uterine or vaginal vault) prolapse stage II with or without concomitant anterior vaginal wall prolapse ≥ stage 2 according to the pelvic organ prolapse quantification (POP-Q) system. Outcome measurements included POP-Q evaluations, prolapse-specific symptom questionnaires, and surgical data. RESULTS: At the end of follow-up 95 out of 98 (96.9%) had an optimal anatomical outcome at the apical segment (POP-Q stage 0-1) in the single center compared with 154 out of 164 (93.9%) in the multicenter study (P = 0.03). There were no serious complications in the single-center study compared with 9 out of 207 (4.3%) in the multicenter study. In patients undergoing surgery for recurrence, the risk ratio for complications overall was 4:1 in favor of the single-center study. There were no significant differences between the studies in any subjective symptom scale. CONCLUSIONS: Compared with multicenter use, large volumes at a single site only resulted in minor improvements of anatomical outcomes and no significant differences with regard to patient-reported outcomes on pelvic organ function or related quality of life. Instead, the greatest benefit of single-center use was the significantly decreased complication rates.
Entities:
Keywords:
Complications; Pelvic organ prolapse; Transvaginal mesh
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