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Long-Term Longitudinal QoL in Patients Undergoing EEA

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ClinicalTrials.gov Identifier: NCT04087902
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Douglas Hardesty, Ohio State University

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
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.

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Study Type : Observational
Estimated 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 : July 16, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2023





Primary Outcome Measures :
  1. PROMIS-29 quality of life outcome measures for patients undergoing endoscopic endonasal surgeries. [ Time Frame: 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 :
  1. ASK Nasal-12 questionnaire used to measure normal time of healing for patients undergoing endoscopic endonasal surgery [ Time Frame: 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.

  2. Number of patients with long-term quality of life risk factors using PROMIS-29 [ Time Frame: 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.

  3. Number of patients with long-term procedural comorbidities using ASK-Nasal 12. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients who are 18 years of age or older and undergoing surgery via Endoscopic Endonasal Approach.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087902


Contacts
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Contact: Joshua Bolender, BS 614-685-8622 Joshua.Bolender@osumc.edu
Contact: Amy Minnema, MS Amy.Minnema@osumc.edu

Locations
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United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Joshua Bolender, BS    614-685-8622    Joshua.Bolender@osumc.edu   
Contact: Amy Minnema, MS       Amy.Minnema@osumc.edu   
Principal Investigator: Douglas Hardesty, MD         
Sub-Investigator: Daniel Prevedello, MD         
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Douglas Hardesty, MD Ohio State University

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Responsible Party: Douglas Hardesty, Assistant Professor, Neurological Surgery, Ohio State University
ClinicalTrials.gov Identifier: NCT04087902     History of Changes
Other Study ID Numbers: 2019H0225
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There will be no sharing of individual participant data with other researchers. Data will be de-identified once analysis is complete and destroyed once manuscripts are written.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Douglas Hardesty, Ohio State University:
Endoscopic Endonasal Approach Surgery
Additional relevant MeSH terms:
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Meningioma
Esthesioneuroblastoma, Olfactory
Chondrosarcoma
Craniopharyngioma
Adamantinoma
Pituitary Neoplasms
Chordoma
Central Nervous System Cysts
Encephalocele
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial