Long-Term Longitudinal QoL in Patients Undergoing EEA

Meningioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04087902
• Other study ID #: 2019H0225
• Status: Recruiting
• Start date: July 16, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Ohio State University
• Contact: Megan Frost, BS
• Phone: 614-685-8622
• Email: Megan.Frost[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chondrosarcoma
• Chordoma
• Craniopharyngioma
• Encephalocele
• Esthesioneuroblastoma
• Esthesioneuroblastoma, Olfactory
• Meningioma
• Pituitary Neoplasms
• Pituitary Tumor
• Rathke Cleft Cysts

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ASK Nasal-12 questionnaire used to measure normal time of healing for patients undergoing endoscopic endonasal surgery	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.	24 months post-operatively
Secondary	Number of patients with long-term quality of life risk factors using PROMIS-29	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.	24 months post-operatively
Secondary	Number of patients with long-term procedural comorbidities using ASK-Nasal 12.	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.	24 months post-operatively