Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 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: August 29, 2016
Last verified: August 2016

November 4, 2009
August 29, 2016
October 2009
December 2017   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01017055 on ClinicalTrials.gov Archive Site
Quality of life as measured by a self-administered 10 point questionnaire. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery
Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery
Evaluate voice and swallowing outcomes post operatively.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients undergoing revision anterior cervical spine surgery
  • Dysphagia
  • Dysphonia
Other: Voice and Swallowing evaluations
Fiberoptic exam to evaluate vocal cord and swallowing function
Voice and Swallowing Evaluations
Intervention: Other: Voice and Swallowing evaluations
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2018
December 2017   (final data collection date for primary outcome measure)

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.
Both
19 Years and older   (Adult, Senior)
No
Contact: Lisa K Clemons, MSN, RN, OCN 205 934-9714 lclemons@uab.edu
United States
 
NCT01017055
F090409003
No
Not Provided
Not Provided
William Carroll, MD, University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
Principal Investigator: William R Carroll, MD University of Alabama at Birmingham
University of Alabama at Birmingham
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP