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


N/A
18 Years
80 Years
Open (Enrolling by invite only)
Both
Pituitary Neoplasm, Pituitary Adenoma, Prolactinoma, Cushings Disease, Acromegaly

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

ASK Nasal symptom severity scores and SF-8 scores

Outcome Description:

Compare symptom severity scores and quality of life scores in first-time surgery patients with nonfunctioning adenomas on the ASK Nasal and SF-8.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Andrew S. Little, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

Authority:

United States: Institutional Review Board

Study ID:

11BN093

NCT ID:

NCT01504399

Start Date:

October 2011

Completion Date:

January 2015

Related Keywords:

  • Pituitary Neoplasm
  • Pituitary Adenoma
  • Prolactinoma
  • Cushings Disease
  • Acromegaly
  • Pituitary surgery
  • Transsphenoidal surgery
  • Anterior skull base surgery
  • Endoscopic surgery
  • Patient survey
  • Nasal complications
  • Acromegaly
  • Adenoma
  • Neoplasms
  • Cushing Syndrome
  • Pituitary ACTH Hypersecretion
  • Pituitary Neoplasms
  • Prolactinoma

Name

Location
Ohio State University Medical Center Columbus, Ohio  43210
NorthShore University health system Evanston, Illinois  60201
Barrow Neurological Institute/St. Joseph's Hospital and Medical Center Phoenix, Arizona  85013
John Wayne Cancer Institute at St. John's Health Center Santa Monica, California  90404