Long-Term Longitudinal QoL in Patients Undergoing EEA

NCT04087902 | Active Not Recruiting

• 1 other identifier: 2019H0225
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pituitary Tumor; Meningioma; Rathke Cleft Cysts; Chordoma; Chondrosarcoma; Craniopharyngioma; Encephalocele; Esthesioneuroblastoma

Keywords

Endoscopic Endonasal Approach Surgery

Outcome Measures

Primary Outcomes (1)

• PROMIS-29 quality of life outcome measures for patients undergoing endoscopic endonasal surgeries.

  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.

  24-months post-operatively

Secondary Outcomes (3)

• ASK Nasal-12 questionnaire used to measure normal time of healing for patients undergoing endoscopic endonasal surgery

  24 months post-operatively

• Number of patients with long-term quality of life risk factors using PROMIS-29

  24 months post-operatively

• Number of patients with long-term procedural comorbidities using ASK-Nasal 12.

  24 months post-operatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are 18 years of age or older and undergoing surgery via Endoscopic Endonasal Approach.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Pituitary Neoplasms; Meningioma; Central Nervous System Cysts; Chordoma; Chondrosarcoma; Craniopharyngioma; Encephalocele; Esthesioneuroblastoma, Olfactory

Condition Hierarchy (Ancestors)

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

Study Officials

• Kyle Wu, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Neurological Surgery

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: September 12, 2019
• Study Start: July 16, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)