Brief Title
Rhinological Outcomes in Endonasal Pituitary Surgery
Official Title
Rhinological Outcomes in Endonasal Pituitary Surgery: A Multi-Center Observational Cohort Study
Brief 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.
Study Type
Observational
Primary Outcome
ASK Nasal symptom severity scores and SF-8 scores
Secondary Outcome
ASK Nasal symptom severity scores
Condition
Pituitary Neoplasm
Study Arms / Comparison Groups
Microscopic:
Description: Microscopic (single nostril, direct endonasal with nasal speculum)transsphenoidal nasal surgery
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
235
Start Date
October 1, 2011
Completion Date
December 9, 2015
Primary Completion Date
June 1, 2014
Eligibility Criteria
Inclusion Criteria: - Pituitary tumor patients treated by transsphenoidal route - Adults (age 18-80 years) - Direct endonasal or endoscopic approach - Non-functioning adenoma, Cushing's disease, acromegaly Exclusion Criteria: - Patients treated by expanded endonasal approaches (transtubercular approach) - Sublabial approach
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Andrew S. Little, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01504399
Organization ID
11BN093
Responsible Party
Sponsor
Study Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Study Sponsor
Andrew S. Little, MD, Principal Investigator, Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Verification Date
August 2018