Long-Term Longitudinal QoL in Patients Undergoing EEA

Overview

This is a prospective longitudinal study to access postoperative 2-year quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base.

Full Title of Study: “A Prospective Longitudinal Quality of Life Study in Patients Undergoing Endoscopic Endonasal Skull Base Surgery”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2025

Detailed Description

This is a prospective single-institution longitudinal study to access quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base. Patients will be followed before surgery and up to twenty-four months post-surgery. The primary goal of the study is to assess the alterations to patient quality of life following endoscopic endonasal surgery using modern sinonasal reconstruction techniques. Secondary goals are to better understand the time course of normal healing and patient/procedural risk factors associated with poorer quality of life outcomes.

Clinical Trial Outcome Measures

Primary Measures

  • PROMIS-29 quality of life outcome measures for patients undergoing endoscopic endonasal surgeries.
    • Time Frame: 24-months post-operatively
    • This study aims to better understand the long-term overall quality of life of patients undergoing endoscopic endonasal surgery using modern sinonasal reconstruction techniques. The PROMIS-29 metric, an overall quality of life metric, will be used to better understand quality of life for patients undergoing this procedure.

Secondary Measures

  • ASK Nasal-12 questionnaire used to measure normal time of healing for patients undergoing endoscopic endonasal surgery
    • Time Frame: 24 months post-operatively
    • This study aims to better understand the overall nose function in patients undergoing endoscopic endonasal surgery using modern sinonasal techniques. The ASK Nasal-12 metric is designed to evaluate nose overall nose function such as post-nasal drip, ability to smell, and pain.
  • Number of patients with long-term quality of life risk factors using PROMIS-29
    • Time Frame: 24 months post-operatively
    • This study aims to better understand the number of long-term risk factors for patients undergoing endoscopic endonasal surgeries using modern sinonasal reconstruction techniques. This will be done using the PROMIS-29 metric along with patient data.
  • Number of patients with long-term procedural comorbidities using ASK-Nasal 12.
    • Time Frame: 24 months post-operatively
    • This study aims to better understand the number of long-term comorbidities for patients undergoing endonasal endoscopic surgeries using modern sinonasal reconstruction techniques. This will be done using the ASK-Nasal 12 metric along with patient data.

Participating in This Clinical Trial

Inclusion Criteria

  • Patient is scheduled to undergo endoscopic endonasal surgery. Multiple, staged surgeries are not exclusionary – 18 years of age or older – The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent Exclusion Criteria:

  • Patient is a prisoner – Patient is not English speaking – Patient is not expected to survive until the 2-year follow-up

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Ohio State University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kyle Wu, Assistant Professor, Neurological Surgery – Ohio State University
  • Overall Official(s)
    • Kyle Wu, MD, Principal Investigator, Ohio State University
  • Overall Contact(s)
    • Megan Frost, BS, 614-685-8622, Megan.Frost@osumc.edu

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