Elisabeth Erekson1, Shawn Menefee2, Ryan E Whitworth3, Cindy L Amundsen4, Lily A Arya5, Yuko M Komesu6, Cecile A Ferrando7, Halina M Zyczynski8, Vivian W Sung9, David D Rahn10, Jasmine Tan-Kim2, Donna Mazloomdoost11, Marie G Gantz3, Holly E Richter12. 1. From the Department of Obstetrics and Gynecology, The Geisel School of Medicine at Dartmouth, Hanover, NH. 2. University of California, San Diego, and Kaiser Permanente, San Diego, CA. 3. RTI International, Research Triangle Park. 4. Duke University Medical Center, Durham, NC. 5. University of Pennsylvania, Philadelphia, PA. 6. University of New Mexico Health Sciences Center, Albuquerque, NM. 7. Department of Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH. 8. The Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Magee-Womens Research Institute, Pittsburgh, PA. 9. Alpert Medical School of Brown University, Providence, RI. 10. University of Texas Southwestern Medical Center, Dallas, TX. 11. The Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD. 12. University of Alabama at Birmingham, Birmingham, AL.
Abstract
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.
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.
Authors: Linda P Fried; Luigi Ferrucci; Jonathan Darer; Jeff D Williamson; Gerard Anderson Journal: J Gerontol A Biol Sci Med Sci Date: 2004-03 Impact factor: 6.053
Authors: Thomas N Robinson; Daniel S Wu; Lauren Pointer; Christina L Dunn; Joseph C Cleveland; Marc Moss Journal: Am J Surg Date: 2013-07-20 Impact factor: 2.565
Authors: Sallis O Yip; Madeline A Dick; Alexandra M McPencow; Deanna K Martin; Maria M Ciarleglio; Elisabeth A Erekson Journal: Am J Obstet Gynecol Date: 2012-11-15 Impact factor: 8.661
Authors: Matthew D Barber; Linda Brubaker; Ingrid Nygaard; Thomas L Wheeler; Joeseph Schaffer; Zhen Chen; Cathie Spino Journal: Obstet Gynecol Date: 2009-09 Impact factor: 7.661
Authors: Ingrid Nygaard; Matthew D Barber; Kathryn L Burgio; Kimberly Kenton; Susan Meikle; Joseph Schaffer; Cathie Spino; William E Whitehead; Jennifer Wu; Debra J Brody Journal: JAMA Date: 2008-09-17 Impact factor: 56.272
Authors: Thomas N Robinson; Ben Eiseman; Jeffrey I Wallace; Skotti D Church; Kim K McFann; Shirley M Pfister; Terra J Sharp; Marc Moss Journal: Ann Surg Date: 2009-09 Impact factor: 12.969
Authors: Robert E Gutman; Ingrid E Nygaard; Wen Ye; David D Rahn; Matthew D Barber; Halina M Zyczynski; Leslie Rickey; Charles W Nager; R Edward Varner; Kimberly Kenton; Kimberly J Dandreo; Holly E Richter Journal: Am J Obstet Gynecol Date: 2012-11-03 Impact factor: 8.661
Authors: Thomas N Robinson; Daniel S Wu; Angela Sauaia; Christina L Dunn; Jennifer E Stevens-Lapsley; Marc Moss; Greg V Stiegmann; Csaba Gajdos; Joseph C Cleveland; Sharon K Inouye Journal: Ann Surg Date: 2013-10 Impact factor: 12.969