Rhinological Outcomes in Endonasal Pituitary Surgery
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Rhinological Outcomes in Endonasal Pituitary Surgery: A Multi-Center Observational Cohort Study|
- ASK Nasal symptom severity scores and SF-8 scores [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Microscopic (single nostril, direct endonasal with nasal speculum)transsphenoidal nasal surgery
Fully endoscopic: (bi-nostril, no nasal speculum) transsphenoidal pituitary surgery
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|