The Design of a Prospective Trial to Evaluate the Role of Preoperative Frailty Assessment in Older Women Undergoing Surgery for the Treatment of Pelvic Organ Prolapse: The FASt Supplemental Trial.
Journal Article (Journal Article)
OBJECTIVE: We present the rationale for and the design of a prospective trial to evaluate the role of preoperative frailty and mobility assessments in older women undergoing surgery for the treatment of pelvic organ prolapse (POP) as a planned prospective supplemental trial to the ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design) trial. The Frailty ASPIRe Study (FASt) examines the impact of preoperative frailty and mobility on surgical outcomes in older women (≥65 years) participating in the ASPIRe trial. The primary objective of FASt is to determine the impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgery for POP. METHODS: The selection of the preoperative assessments, primary outcome measures, and participant inclusion is described. Frailty and mobility measurements will be collected at the preoperative visit and include the 6 Robinson frailty measurements and the Timed Up and Go mobility test. The main outcome measure in the FASt supplemental study will be moderate to severe postoperative adverse events according to the Clavien-Dindo Severity Classification. CONCLUSIONS: This trial will assess impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgical procedures for the correction of apical POP. Information from this trial may help both primary care providers and surgeons better advise/inform women on their individual risks of surgical complications and provide more comprehensive postoperative care to women at highest risk of complications.
Full Text
Duke Authors
Cited Authors
- Erekson, E; Menefee, S; Whitworth, RE; Amundsen, CL; Arya, LA; Komesu, YM; Ferrando, CA; Zyczynski, HM; Sung, VW; Rahn, DD; Tan-Kim, J; Mazloomdoost, D; Gantz, MG; Richter, HE; Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network (PFDN),
Published Date
- January 1, 2021
Published In
Volume / Issue
- 27 / 1
Start / End Page
- e106 - e111
PubMed ID
- 32217922
Pubmed Central ID
- PMC7381379
Electronic International Standard Serial Number (EISSN)
- 2154-4212
Digital Object Identifier (DOI)
- 10.1097/SPV.0000000000000833
Language
- eng
Conference Location
- United States