Long-Term Longitudinal QoL in Patients Undergoing EEA
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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.
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 Outcome 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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Patients who are 18 years of age or older and undergoing surgery via Endoscopic Endonasal Approach.
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
Patient is a prisoner
Patient is not English speaking
Patient is not expected to survive until the 2-year follow-up
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
There will be no sharing of individual participant data with other researchers. Data will be de-identified once analysis is complete and destroyed once manuscripts are written.
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Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Douglas Hardesty, Ohio State University:
Endoscopic Endonasal Approach Surgery
Additional relevant MeSH terms:
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Central Nervous System Cysts
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial