Assessing quality of life after endoscopic surgery for skull base tumors
A Prospective Longitudinal Quality of Life Study in Patients Undergoing Endoscopic Endonasal Skull Base Surgery
This study looks at how people's quality of life changes after they have surgery for skull base tumors, like pituitary tumors, over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT04087902 on ClinicalTrials.gov |
What this trial studies
This observational study follows patients undergoing endoscopic endonasal approach surgeries for skull base tumors, including pituitary tumors and meningiomas, to evaluate their quality of life over a two-year period post-surgery. Patients will be assessed before surgery and at multiple intervals up to 24 months afterward to understand how their quality of life changes following the procedure. The study aims to identify factors that may influence recovery and quality of life outcomes, utilizing modern sinonasal reconstruction techniques.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for endoscopic endonasal surgery and can comply with study requirements.
Not a fit: Patients who are prisoners, non-English speakers, or not expected to survive until the 2-year follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into improving postoperative care and quality of life for patients undergoing skull base surgeries.
How similar studies have performed: While there have been studies on quality of life post-surgery, this specific longitudinal approach focusing on endoscopic endonasal surgeries is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio
- Ohio State University — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Kyle Wu, MD — Ohio State University
- Study coordinator: Megan Frost, BS
- Email: Megan.Frost@osumc.edu
- Phone: 614-685-8622
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.