Post-operative Cognitive Function Following Pelvic Floor Surgery

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT04554550
Collaborator
(none)
130
1
18.5
7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    130 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Post-operative Cognitive Function Following Pelvic Floor Surgery
    Actual Study Start Date :
    Aug 13, 2020
    Actual Primary Completion Date :
    Feb 28, 2022
    Actual Study Completion Date :
    Feb 28, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Change in episodic memory neurocognitive test scores [8 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania

    Investigators

    • Principal Investigator: Uduak Andy, MD, University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Uduak Andy, Assistant Professor of Obstetrics and Gynecology, University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT04554550
    Other Study ID Numbers:
    • 843178
    First Posted:
    Sep 18, 2020
    Last Update Posted:
    Jul 25, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 25, 2022