ClinicalTrials.gg
Active, not recruitingNCT04087902Updated May 20, 2026

Long-Term Longitudinal QoL in Patients Undergoing EEA

An observational study in Pituitary Tumor, Meningioma and Rathke Cleft Cysts, sponsored by Ohio State University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.

Sponsored by Ohio State University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pituitary Tumor
  • Meningioma
  • Rathke Cleft Cysts
  • Chordoma
  • Chondrosarcoma
  • Craniopharyngioma
  • Encephalocele
  • Esthesioneuroblastoma

Keywords

  • Endoscopic Endonasal Approach Surgery
03

In context

Pituitary Neoplasms

200 studies on the registry are indexed under Pituitary Neoplasms; 51 are open to participants now.

This study's planned enrollment of 400 is above the median of 163 across 74 observational studies indexed under Pituitary Neoplasms.

Browse Pituitary Neoplasms studies →

Lead sponsor

Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients who are 18 years of age or older and undergoing surgery via Endoscopic Endonasal Approach.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • Patient is a prisoner
  • Patient is not English speaking
  • Patient is not expected to survive until the 2-year follow-up
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. PROMIS-29 quality of life outcome measures for patients undergoing endoscopic endonasal surgeries.

    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.

    Time frame: 24-months post-operatively

Secondary outcomes

  1. ASK Nasal-12 questionnaire used to measure normal time of healing for patients undergoing endoscopic endonasal surgery

    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.

    Time frame: 24 months post-operatively

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

    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.

    Time frame: 24 months post-operatively

  3. Number of patients with long-term procedural comorbidities using ASK-Nasal 12.

    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.

    Time frame: 24 months post-operatively

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2019 (actual). Primary completion is estimated for Dec 2026, 89 months after the start.

Of 33 observational studies under Pituitary Neoplasms, half reached primary completion within 163 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 349. This study's planned 89 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2019
First posted
Sep 12, 2019
StartActual
Jul 16, 2019
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2027
Last update
May 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04087902
Responsible party
Kyle Wu (Assistant Professor, Neurological Surgery, Ohio State University) — Principal investigator
First posted
Sep 12, 2019
Start date
Jul 16, 2019
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
May 20, 2026

Study contacts

Kyle Wu, MD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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