Barrow Nasal Inventory Survey

The purpose of this study is to evaluate patient nasal outcome following endo-nasal surgery. This type of surgery is conducted for pituitary and skull base tumors. There is no published data on trauma to the nose during surgery and how it impacts nasal functioning. The investigators propose to develop a survey and administer it to patients before and after surgery to learn about their perception of nasal functioning.

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Key information

Conditions

Pituitary Tumors Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hypothalamic Diseases Hypothalamic Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pituitary Diseases Pituitary Neoplasms Supratentorial Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

About this study

A 9-item patient survey (the ASK Nasal Inventory) focusing on the most common postoperative complaints, such as crusting, sinusitis, pain, and ease of breathing, was developed by the anterior skull base team at the Barrow Neurological Institute. Content was validated in structured patient interviews by four subject-matter experts with both endonasal and control groups. Eligible patients for the control group included patients undergoing any neurosurgical procedure requiring anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, and shunting procedures. This survey was self-administered pre- and 3 months post-surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults with planned endonasal surgery for pituitary tumor or skull base lesion

Exclusion criteria

Children

Treatment and study plan

Primary outcomes

Change in Mean Survey Response From Baseline to 90 Days Post Surgery

Time frame: Baseline, 90 days post surgery

Mean survey response at 90 days post surgery between the control patients and the endonasal surgery patients using the Anterior skull base nasal inventory (ASK Nasal Inventory. A 5-point Likert scale for each question on the ASK Nasal inventory measures frequency of nasal symptoms where 1=never, 2= a little of the time, 3=some of the time, 4=most of the time, 5= all of the time. Total mean Likert scores were compared in the endonasal group to the control group after surgery. Scores range from minimum of 9 to maximum of 45. The lower the score the fewer the nasal complaints.

Secondary outcomes

Test-retest Reliability of the ASK Nasal Inventory

Time frame: 90 days and 120 days post surgery

First 12 endonasal and 10 control patients enrolled in the study completed the ASK Nasal Inventory at 90 days and 120 days post surgery to measure reliablity of the survey (they scored the 9-item instrument similarly at both time frames)comparing 5-point Likert scale scores. Pearson correlation was used to determine a correlation between each patient's responses at 90 days post op and 120 days post op.

Sponsors and collaborators

Lead sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Other

Registry information

Official study title

Observational Study of Nasal Outcomes Following Endonasal Surgery for Anterior Skull Base Lesions

Acronym: BNI

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Mar 25, 2011
Registry last updated: Dec 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed