Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 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: October 9, 2014
Last verified: March 2014
  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:


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 2016
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 9, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 20, 2014