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:
University of Alabama at Birmingham
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
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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
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 February 25, 2015