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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 5, 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
November 4, 2009
November 20, 2009
September 5, 2017
October 2009
December 2018   (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 ]
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 ]
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 2019
December 2018   (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.
Sexes Eligible for Study: All
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
September 2017