Trial reportAmerican journal of obstetrics and gynecology2026
Outcomes by frailty and mobility in older patients undergoing major urogynecologic surgery: a planned supplementary study of the apical suspension repair for vault prolapse in a three-arm randomized (ASPIRe) trial.
Trial report in American journal of obstetrics and gynecology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectiveThe impact of frailty and compromised mobility on immediate postoperative complications, geriatric outcomes, and treatment failure after prolapse surgery remains uncertain. The objective of this study was to prospectively characterize frailty and mobility and their impact on immediate postoperative complications, geriatric outcomes, and treatment success in older patients undergoing major urogynecologic surgery for pelvic organ prolapse. STUDY
designA nested prospective cohort study within a 3-arm randomized clinical trial was conducted at 9 clinical sites in 146 participants. Participants aged ≥65 years with symptomatic vaginal vault prolapse underwent baseline assessments of frailty and compromised mobility. Frailty was measured using the Robinson Frailty Index. The Robinson Frailty Index score ranges from 0 to 7 and scores ≥2 were considered prefrail/frail. Compromised mobility was defined as Timed Up and Go ≥15 seconds, use of an assistive device, or observed gait difficulties. The primary outcome was immediate postoperative moderate to severe adverse events assessed according to the Clavien-Dindo Severity Classification (grade≥II). Geriatric-specific outcomes included 30-day postoperative complications, need for increased social support assessed 6 weeks postoperatively, falls, new admission to skilled nursing facilities, all-cause hospital admissions, and mortality. Treatment outcome was time to composite treatment failure. Geriatric and treatment outcomes were assessed biannually for 36 up to 60 months.
results146 supplemental study participants underwent randomized prolapse surgery in the main trial: 50 in the transvaginal native tissue repair, 47 in the abdominal sacral colpopexy, and 48 in the transvaginal mesh repair arms. Compared with nonfrail subjects, prefrail/frail participants experienced no difference in geriatric-specific outcomes. Prefrail/frail participants living alone before surgery were more likely to require support (family/friends or assistance) in the first 6 weeks after surgery (19% vs 6%, P=.04). Prefrail/frail and compromised mobility participants had a shorter time to surgical treatment failure than did nonfrail or noncompromised patients (frail vs nonfrail adjusted hazard ratio, 2.1; 95% confidence interval, 1.2, 3.6).
conclusionDespite measurable frailty or compromised mobility, many older patients underwent prolapse surgery with few complications; however, enhanced social support was needed in the first 6 weeks after surgery. Treatment failure was higher in patients with preoperative frailty, suggesting that frailty is important to incorporate in surgical treatment planning for the correction of pelvic organ prolapse in older patients.
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