Clinical trial NCT01504399: Rhinological Outcomes in Endonasal Pituitary Surgery
Official title: Rhinological Outcomes in Endonasal Pituitary Surgery: A Multi-Center Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pituitary Neoplasm
Pituitary Adenoma
Prolactinoma
Cushings Disease
Acromegaly
Keywords: Pituitary surgery
Transsphenoidal surgery
Anterior skull base surgery
Endoscopic surgery
Patient survey
Nasal complications
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: ASK Nasal symptom severity scores and SF-8 scores
timeFrame: 3 months
measure: Validation of ASK Nasal survey tool
timeFrame: 3 months
Secondary outcomes:
measure: ASK Nasal symptom severity scores
timeFrame: 2 weeks, 3 months, 6 months postoperative
measure: Impact of surgical techniques and complications on ASK Nasal scores
timeFrame: 6 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute/St. Joseph's Hospital and Medical Center
state: Arizona
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute at St. John's Health Center
state: California
city: Chicago
country: United States
facility: Northshore University Health System
state: Illinois
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
name: Andrew S. Little, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Zaidi HA, Awad AW, Bohl MA, Chapple K, Knecht L, Jahnke H, White WL, Little AS. Comparison of outcomes between a less experienced surgeon using a fully endoscopic technique and a very experienced surgeon using a microscopic transsphenoidal technique for pituitary adenoma. J Neurosurg. 2016 Mar;124(3):596-604. doi: 10.3171/2015.4.JNS15102. Epub 2015 Oct 16.
citation: Little AS, Kelly DF, Milligan J, Griffiths C, Prevedello DM, Carrau RL, Rosseau G, Barkhoudarian G, Jahnke H, Chaloner C, Jelinek KL, Chapple K, White WL. Comparison of sinonasal quality of life and health status in patients undergoing microscopic and endoscopic transsphenoidal surgery for pituitary lesions: a prospective cohort study. J Neurosurg. 2015 Sep;123(3):799-807. doi: 10.3171/2014.10.JNS14921. Epub 2015 Apr 17.
citation: Little AS, Kelly D, Milligan J, Griffiths C, Prevedello DM, Carrau RL, Rosseau G, Barkhoudarian G, Otto BA, Jahnke H, Chaloner C, Jelinek KL, Chapple K, White WL. Predictors of sinonasal quality of life and nasal morbidity after fully endoscopic transsphenoidal surgery. J Neurosurg. 2015 Jun;122(6):1458-65. doi: 10.3171/2014.10.JNS141624. Epub 2015 Apr 3.
citation: Little AS, Kelly D, Milligan J, Griffiths C, Rosseau G, Prevedello DM, Carrau R, Jahnke H, Chaloner C, O'Leary J, Chapple K, Nakaji P, White WL. Prospective validation of a patient-reported nasal quality-of-life tool for endonasal skull base surgery: The Anterior Skull Base Nasal Inventory-12. J Neurosurg. 2013 Oct;119(4):1068-74. doi: 10.3171/2013.3.JNS122032. Epub 2013 May 10.