Rhinological Outcomes in Endonasal Pituitary Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier:
NCT01504399
First received: January 3, 2012
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition
Pituitary Neoplasm
Pituitary Adenoma
Prolactinoma
Cushings Disease
Acromegaly

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rhinological Outcomes in Endonasal Pituitary Surgery: A Multi-Center Observational Cohort Study

Resource links provided by NLM:


Further study details as provided by St. Joseph's Hospital and Medical Center, Phoenix:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: January 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Microscopic:
Microscopic (single nostril, direct endonasal with nasal speculum)transsphenoidal nasal surgery
Endoscopic
Fully endoscopic: (bi-nostril, no nasal speculum) transsphenoidal pituitary surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with pituitary lesions referred to our investigators for surgical management by either microscopic or endoscopic transspenoidal surgical resection.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504399

Locations
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
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Investigators
Principal Investigator: Andrew S. Little, MD Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT01504399     History of Changes
Other Study ID Numbers: 11BN093
Study First Received: January 3, 2012
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Joseph's Hospital and Medical Center, Phoenix:
Pituitary surgery
Transsphenoidal surgery
Anterior skull base surgery
Endoscopic surgery
Patient survey
Nasal complications

Additional relevant MeSH terms:
Pituitary Neoplasms
Acromegaly
Adenoma
Neoplasms
Cushing Syndrome
Pituitary ACTH Hypersecretion
Prolactinoma
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms

ClinicalTrials.gov processed this record on July 28, 2014