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NCT Number: NCT01504399

Rhinological Outcomes in Endonasal Pituitary Surgery

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.

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Key information

Conditions

Pituitary Neoplasm Acromegaly Adenoma Adrenal Gland Diseases Adrenocortical Hyperfunction Bone Diseases Bone Diseases, Endocrine Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cushings Disease Endocrine Gland Neoplasms Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Hypothalamic Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Nervous System Neoplasms Pituitary Adenoma Pituitary Diseases Pituitary Neoplasms Prolactinoma Supratentorial Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Barrow Neurological Institute/St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

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About this 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. Validation of ASK Nasal survey tool

    Time frame: 3 months

    Validate a nasal outcomes scale (ASK Nasal) specifically designed for anterior skull base surgery.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jan 5, 2012
Registry last updated
Aug 22, 2018

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.

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