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Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery

This study is currently recruiting participants.
Verified September 2017 by William Carroll, MD, University of Alabama at Birmingham
Sponsor:
ClinicalTrials.gov Identifier:
NCT01017055
First Posted: November 20, 2009
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
William Carroll, MD, University of Alabama at Birmingham
  Purpose
Evaluate voice and swallowing outcomes post operatively.

Condition Intervention
Dysphagia Dysphonia Other: Voice and Swallowing evaluations

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery

Further study details as provided by William Carroll, MD, University of Alabama at Birmingham:

Primary Outcome Measures:
  • Vocal cord and swallowing function as measured by fiberoptic exam in the otolaryngology clinic pre-op and approximately 3 weeks post op. [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Quality of life as measured by a self-administered 10 point questionnaire. [ Time Frame: 4 weeks ]

Estimated Enrollment: 50
Study Start Date: October 2009
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Voice and Swallowing Evaluations Other: Voice and Swallowing evaluations
Fiberoptic exam to evaluate vocal cord and swallowing function

Detailed Description:
Anterior Cervical Decompression and fusion is one of the most common spinal surgical procedures performed in the United States. Common complications of this type of surgery are difficulty swallowing and nerve dysfunction that can effect voice. The chance of having voice and swallowing disturbances increases if this type of surgery has to be repeated. The purpose of this study is to document the voice and swallowing function of patients undergoing this type of surgery in an effort to find better ways to identify and treat these common complications.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing revision anterior cervical spine surgery
Criteria

Inclusion Criteria:

  • Patients undergoing revision anterior cervical spine surgery

Exclusion Criteria:

  • Primary pathology of the upper aero-digestive tract other than mild chronic pharyngitis, pre-existing vocal cord paralysis.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017055


Contacts
Contact: Lisa K Clemons, MSN, RN, OCN 205 934-9714 lclemons@uab.edu

Locations
United States, Alabama
UAB Recruiting
Birmingham, Alabama, United States, 35233
Contact: Lisa K Clemons, RN, MSN, OCN    205-934-9714    lclemons@uab.edu   
Principal Investigator: William R Carroll, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: William R Carroll, MD University of Alabama at Birmingham
  More Information

Responsible Party: William Carroll, MD, Professor of Surgery, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01017055     History of Changes
Other Study ID Numbers: F090409003
First Submitted: November 4, 2009
First Posted: November 20, 2009
Last Update Posted: September 4, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Dysphonia
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms