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Rhinological Outcomes in Endonasal Pituitary Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01504399
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

Tracking Information
First Submitted Date January 3, 2012
First Posted Date January 5, 2012
Last Update Posted Date August 22, 2018
Actual Study Start Date October 1, 2011
Actual Primary Completion Date June 1, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 3, 2012)
  • 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 Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 3, 2012)
  • 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 Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rhinological Outcomes in Endonasal Pituitary Surgery
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 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Pituitary Neoplasm
  • Pituitary Adenoma
  • Prolactinoma
  • Cushings Disease
  • Acromegaly
Intervention Not Provided
Study 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 21, 2018)
235
Original Estimated Enrollment
 (submitted: January 3, 2012)
300
Actual Study Completion Date December 9, 2015
Actual Primary Completion Date June 1, 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01504399
Other Study ID Numbers 11BN093
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party St. Joseph's Hospital and Medical Center, Phoenix
Study Sponsor St. Joseph's Hospital and Medical Center, Phoenix
Collaborators Not Provided
Investigators
Principal Investigator: Andrew S. Little, MD Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
PRS Account St. Joseph's Hospital and Medical Center, Phoenix
Verification Date August 2018