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Clinical Trials/NCT04554550
NCT04554550
Completed
N/A

Post-operative Cognitive Function Following Pelvic Floor Surgery

University of Pennsylvania1 site in 1 country130 target enrollmentAugust 13, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
University of Pennsylvania
Enrollment
130
Locations
1
Primary Endpoint
Change in episodic memory neurocognitive test scores
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 13, 2020
End Date
February 28, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Uduak Andy

Assistant Professor of Obstetrics and Gynecology

University of Pennsylvania

Eligibility Criteria

Inclusion Criteria

  • Women 60 years of age or older who are scheduled to undergo surgery for pelvic organ prolapse.

Exclusion Criteria

  • Women who have a known baseline diagnosis of cognitive dysfunction or central nervous disorder
  • A Mini-Mental State Exam (MMSE) score of greater than 24
  • Non-english speaking
  • Any severe visual or auditory disorder
  • Alcoholism or drug dependence

Outcomes

Primary Outcomes

Change in episodic memory neurocognitive test scores

Time Frame: 8 weeks

Episodic memory will be assessed using the Scene Encoding/Recognition Test

Study Sites (1)

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