Long-Term Longitudinal QoL in Patients Undergoing EEA

NCT ID: NCT04087902

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-16

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pituitary Tumor Meningioma Rathke Cleft Cysts Chordoma Chondrosarcoma Craniopharyngioma Encephalocele Esthesioneuroblastoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Kyle Wu

Assistant Professor, Neurological Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyle Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Megan Frost, BS

Role: CONTACT

614-685-8622

Facility Contacts

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Megan Frost, BS

Role: primary

614-685-8622

Other Identifiers

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2019H0225

Identifier Type: -

Identifier Source: org_study_id

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