Long-Term Longitudinal QoL in Patients Undergoing EEA

The Ohio State University

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT04087902

2019H0225

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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