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 : October 24, 2023
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Condition or disease |
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Pituitary Tumor Meningioma Rathke Cleft Cysts Chordoma Chondrosarcoma Craniopharyngioma Encephalocele Esthesioneuroblastoma |
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, 2025 |
Estimated Study Completion Date : | December 31, 2025 |
- 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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
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
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
Contact: Megan Frost, BS | 614-685-8622 | Megan.Frost@osumc.edu |
United States, Ohio | |
Ohio State University | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Megan Frost, BS 614-685-8622 Megan.Frost@osumc.edu | |
Principal Investigator: Kyle Wu, MD | |
Sub-Investigator: Daniel Prevedello, MD |
Principal Investigator: | Kyle Wu, MD | Ohio State University |
Responsible Party: | Kyle Wu, Assistant Professor, Neurological Surgery, Ohio State University |
ClinicalTrials.gov Identifier: | NCT04087902 |
Other Study ID Numbers: |
2019H0225 |
First Posted: | September 12, 2019 Key Record Dates |
Last Update Posted: | October 24, 2023 |
Last Verified: | October 2023 |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Endoscopic Endonasal Approach Surgery |
Meningioma Chondrosarcoma Esthesioneuroblastoma, Olfactory Pituitary Neoplasms Craniopharyngioma Adamantinoma 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 Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Sarcoma Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial |