Post-operative Cognitive Function Following Pelvic Floor Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04554550

Enrollment

130

Registered

2020-09-18

Start date

2020-08-13

Completion date

2022-02-28

Last updated

2022-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

60 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results