Rhinological Outcomes in Endonasal Pituitary Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

235 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-01

Study Completion Date

2015-12-09

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.

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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.

Conditions

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Pituitary Neoplasm Pituitary Adenoma Prolactinoma Cushings Disease Acromegaly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Microscopic:

Microscopic (single nostril, direct endonasal with nasal speculum)transsphenoidal nasal surgery

No interventions assigned to this group

Endoscopic

Fully endoscopic: (bi-nostril, no nasal speculum) transsphenoidal pituitary surgery

No interventions assigned to this group

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