Long-Term Longitudinal QoL in Patients Undergoing EEA

Sponsor

Ohio State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04087902

Collaborator

(none)

400

Enrollment

Location

65.5

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pituitary Tumor Meningioma Rathke Cleft Cysts Chordoma Chondrosarcoma Craniopharyngioma Encephalocele Esthesioneuroblastoma

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 16, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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