Clinical Trial: Rhinological Outcomes in Endonasal Pituitary Surgery

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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 Summary:

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.


Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: St. Joseph's Hospital and Medical Center, Phoenix

Dates:
Date Received: January 3, 2012
Date Started: October 2011
Date Completion: December 2017
Last Updated: October 10, 2016
Last Verified: October 2016