Rhinological Outcomes in Endonasal Pituitary Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01504399|
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : August 22, 2018
|Condition or disease|
|Pituitary Neoplasm Pituitary Adenoma Prolactinoma Cushings Disease Acromegaly|
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|
|Actual Enrollment :||235 participants|
|Official Title:||Rhinological Outcomes in Endonasal Pituitary Surgery: A Multi-Center Observational Cohort Study|
|Actual Study Start Date :||October 1, 2011|
|Actual Primary Completion Date :||June 1, 2014|
|Actual Study Completion Date :||December 9, 2015|
Microscopic (single nostril, direct endonasal with nasal speculum)transsphenoidal nasal surgery
Fully endoscopic: (bi-nostril, no nasal speculum) transsphenoidal pituitary surgery
- ASK Nasal symptom severity scores and SF-8 scores [ Time Frame: 3 months ]Compare symptom severity scores and quality of life scores in first-time surgery patients with nonfunctioning adenomas on the ASK Nasal and SF-8.
- Validation of ASK Nasal survey tool [ Time Frame: 3 months ]Validate a nasal outcomes scale (ASK Nasal) specifically designed for anterior skull base surgery.
- ASK Nasal symptom severity scores [ Time Frame: 2 weeks, 3 months, 6 months postoperative ]
- Evaluate the symptom severity scores on the ASK Nasal for first time surgery patients with nonfuctioning adenomas at the first post-operative visit and at 6 months.
- Evaluate the symptom severity scores on the ASK Nasal for all patients at the first post-operative visit and at 6 months.
- Impact of surgical techniques and complications on ASK Nasal scores [ Time Frame: 6 months ]
- Subgroup analysis on the impact of such surgical techniques, such as middle turbinate resection and nasal packing, on ASK Nasal scores will be performed.
- Subgroup analysis of rhinological complications, such as sinusitis, on ASK Nasal scores.
- Objective intranasal endoscopy findings at follow-up visits.
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): NCT01504399
|United States, Arizona|
|Barrow Neurological Institute/St. Joseph's Hospital and Medical Center|
|Phoenix, Arizona, United States, 85013|
|United States, California|
|John Wayne Cancer Institute at St. John's Health Center|
|Santa Monica, California, United States, 90404|
|United States, Illinois|
|Northshore University Health System|
|Chicago, Illinois, United States, 60640|
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Andrew S. Little, MD||Barrow Neurological Institute at St. Joseph's Hospital and Medical Center|