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NCT04554550 Clinical Trial

Post-operative Cognitive Function Following Pelvic Floor Surgery

Pelvic Organ Prolapse Clinical Trial

Official title:
Post-operative Cognitive Function Following Pelvic Floor Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04554550
Other study ID # 843178
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 13, 2020
Est. completion date February 28, 2022

Study information
Verified date July 2022
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date February 28, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender Female
Age group 60 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in episodic memory neurocognitive test scores Episodic memory will be assessed using the Scene Encoding/Recognition Test 8 weeks
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