Rhinological Outcomes in Endonasal Pituitary Surgery

Acromegaly Clinical Trial

Official title:

Rhinological Outcomes in Endonasal Pituitary Surgery: A Multi-Center Observational Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504399
• Other study ID #: 11BN093
• Status: Completed
• Start date: October 1, 2011
• Est. completion date: December 9, 2015

Study information

• Verified date: August 2018
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: December 9, 2015
• Est. primary completion date: June 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly
• ACTH-Secreting Pituitary Adenoma
• Adenoma
• Cushings Disease
• Pituitary ACTH Hypersecretion
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasm
• Pituitary Neoplasms
• Prolactinoma

Locations

Country	Name	City	State
United States	Northshore University Health System	Chicago	Illinois
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Barrow Neurological Institute/St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	John Wayne Cancer Institute at St. John's Health Center	Santa Monica	California

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

Little AS, Jahnke H, Nakaji P, Milligan J, Chapple K, White WL. The anterior skull base nasal inventory (ASK nasal inventory): a clinical tool for evaluating rhinological outcomes after endonasal surgery for pituitary and cranial base lesions. Pituitary. 2012 Dec;15(4):513-7. doi: 10.1007/s11102-011-0358-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASK Nasal symptom severity scores and SF-8 scores	Compare symptom severity scores and quality of life scores in first-time surgery patients with nonfunctioning adenomas on the ASK Nasal and SF-8.	3 months
Primary	Validation of ASK Nasal survey tool	Validate a nasal outcomes scale (ASK Nasal) specifically designed for anterior skull base surgery.	3 months
Secondary	ASK Nasal symptom severity scores	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.	2 weeks, 3 months, 6 months postoperative
Secondary	Impact of surgical techniques and complications on ASK Nasal scores	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.	6 months