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Rhinological Outcomes in Endonasal Pituitary Surgery

St. Joseph's Hospital and Medical Center, Phoenix logo

St. Joseph's Hospital and Medical Center, Phoenix

Status

Completed

Conditions

Cushings Disease
Pituitary Adenoma
Prolactinoma
Acromegaly
Pituitary Neoplasm

Study type

Observational

Funder types

Other

Identifiers

NCT01504399
11BN093

Details and patient eligibility

About

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.

Full 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.

Enrollment

235 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

235 participants in 2 patient groups

Microscopic:
Description:
Microscopic (single nostril, direct endonasal with nasal speculum)transsphenoidal nasal surgery
Endoscopic
Description:
Fully endoscopic: (bi-nostril, no nasal speculum) transsphenoidal pituitary surgery

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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