Rhinological Outcomes in Endonasal Pituitary Surgery

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Rhinological Outcomes in Endonasal Pituitary Surgery

Official Title

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

Brief Summary

      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

      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.

Study Type

Observational

Primary Outcome

ASK Nasal symptom severity scores and SF-8 scores

Secondary Outcome

 ASK Nasal symptom severity scores

Condition

Pituitary Neoplasm

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

235

Start Date

October 1, 2011

Completion Date

December 9, 2015

Primary Completion Date

June 1, 2014

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Andrew S. Little, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01504399

Organization ID

11BN093

Responsible Party

Sponsor

Study Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Study Sponsor

Andrew S. Little, MD, Principal Investigator, Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

Verification Date

August 2018