Rhinological Outcomes in Endonasal Pituitary Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prolactinoma, Pituitary Neoplasm, Pituitary Adenoma, Cushings Disease, Acromegaly

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Microscopic:<br>Microscopic (single nostril, direct endonasal with nasal speculum)transsphenoidal nasal surgery | |
| Endoscopic<br>Fully endoscopic: (bi-nostril, no nasal speculum) transsphenoidal pituitary surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASK Nasal symptom severity scores and SF-8 scores | Compare symptom severity scores and quality of life scores in first-time surgery patients with nonfunctioning adenomas on the ASK Nasal and SF-8. | 3 months | 
| Validation of ASK Nasal survey tool | Validate a nasal outcomes scale (ASK Nasal) specifically designed for anterior skull base surgery. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASK Nasal symptom severity scores | 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 weeks, 3 months, 6 months postoperative | 
| Impact of surgical techniques and complications on ASK Nasal scores | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pituitary surgery, Transsphenoidal surgery, Anterior skull base surgery, Endoscopic surgery, Patient survey, Nasal complications