Rhinological Outcomes in Endonasal Pituitary Surgery

Completed

• Conditions: Pituitary Neoplasm; Prolactinoma; Acromegaly; Pituitary Adenoma; Cushings Disease

• Registration Number: NCT01504399
• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

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 Timeline

• Study Start: 2011-10-01
• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-05
• Primary Completion: 2014-06-01
• Study Completion: 2015-12-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ASK Nasal symptom severity scores and SF-8 scores	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	3 months	Validate a nasal outcomes scale (ASK Nasal) specifically designed for anterior skull base surgery.

Secondary Outcome Measures

Name	Time	Method
ASK Nasal symptom severity scores	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	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.

Trial Locations

Locations (4)

Barrow Neurological Institute/St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

Northshore University Health System; 🇺🇸 Chicago, Illinois, United States

John Wayne Cancer Institute at St. John's Health Center; 🇺🇸 Santa Monica, California, United States

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States