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Trials / Completed

CompletedNCT01504399

Rhinological Outcomes in Endonasal Pituitary Surgery

Rhinological Outcomes in Endonasal Pituitary Surgery: A Multi-Center Observational Cohort Study

Status
Completed
Phase
Study type
Observational
Enrollment
235 (actual)
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

This is a prospective, multi-center observational study designed to address patient-reported nasal outcomes in adults undergoing endoscopic and microscopic surgical removal of pituitary tumors. The primary objective of this study is to determine the difference in nasal outcomes by using the Anterior Skull Base (ASK) Nasal survey between patients treated with endoscopic surgical technique and those treated with microscopic surgical technique. Patients will be given the ASK Nasal survey to assess their nasal functioning and overall health before their surgery, and at post-operative visits 1-2 weeks, 3 months, and 6 months.

Detailed description

The technical and patient factors that influence rhinological (nasal) outcomes following endonasal anterior skull base surgery and pituitary surgery are not well understood. Several timely and controversial topics, such as the influence of endoscopic techniques and the impact of underlying disease on nasal outcomes are in need of further study. The Anterior Skull Base (ASK) Nasal survey is a 24-item questionnaire designed to assess for common postoperative nasal complaints, such as crusting, nasal congestion, pain, sinusitis, sense of smell, and overall functioning. The survey is a brief and simple assessment that asks patients to score symptom severity on a five-point scale.

Conditions

Timeline

Start date
2011-10-01
Primary completion
2014-06-01
Completion
2015-12-09
First posted
2012-01-05
Last updated
2018-08-22

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01504399. Inclusion in this directory is not an endorsement.