Post-operative Cognitive Function Following Pelvic Floor Surgery

Completed

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT04554550
• Lead Sponsor: University of Pennsylvania

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-08-13
• Study First Submitted: 2020-09-12
• Study First Submitted QC: 2020-09-12
• Study First Posted: 2020-09-18
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States