Text Size

Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery

This study is currently recruiting participants.
Verified January 2013 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
William Carroll, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01017055
First received: November 4, 2009
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life as measured by a self-administered 10 point questionnaire. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 4, 2009
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013