Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-29 @ 12:52 PM
Study NCT ID:
NCT04554550
Status:
COMPLETED
Last Update Posted:
2022-07-25
First Post:
2020-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-operative Cognitive Function Following Pelvic Floor Surgery
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Post-operative Cognitive Function Following Pelvic Floor Surgery
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to assess cognitive function before and after surgery for pelvic organ prolapse using sensitive tests of various neurocognitive domains.
Detailed Description:
Post operative cognitive dysfunction has been well described as a relatively common phenomenon with potentially long-lasting detrimental effects. However, there are currently limited data exploring the effects of gynecologic surgery on cognitive function. The population of patients treated surgically for pelvic floor disorders is typically older, and therefore at higher baseline risk for cognitive dysfunction. Therefore, it is of interest to determine the effects of pelvic floor surgery and anesthesia on this patient population. The investigators plan to conduct a prospective cohort study to assess cognitive function before and after pelvic organ prolapse surgery using sensitive tests of memory and other neurocognitive domains. Participants will be women undergoing surgery for pelvic organ prolapse. All participants will undergo cognitive tests at three time points: at their pre-operative clinic appointment, in the hospital the morning after surgery, and at their post-operative clinic appointment. In addition to the neurocognitive tests, patients will undergo a series of questionnaires regarding physical function, frailty, sleep quality, and incontinence symptoms.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: