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NCT Number: NCT04087902

Long-Term Longitudinal QoL in Patients Undergoing EEA

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pituitary Tumor Brain Diseases Brain Neoplasms Central Nervous System Cysts Central Nervous System Diseases Central Nervous System Neoplasms Chondrosarcoma Chordoma Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Craniopharyngioma Encephalocele Endocrine Gland Neoplasms Endocrine System Diseases Esthesioneuroblastoma Esthesioneuroblastoma, Olfactory Hernia Hypothalamic Diseases Hypothalamic Neoplasms Meningeal Neoplasms Meningioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Malformations Nervous System Neoplasms Neural Tube Defects Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Olfactory Nerve Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pituitary Diseases Pituitary Neoplasms Rathke Cleft Cysts Sarcoma Supratentorial Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

A Prospective Longitudinal Quality of Life Study in Patients Undergoing Endoscopic Endonasal Skull Base Surgery

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Sep 12, 2019
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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