Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Construction Approaches
|ClinicalTrials.gov Identifier: NCT00600223|
Recruitment Status : Completed
First Posted : January 24, 2008
Last Update Posted : October 11, 2010
The purpose of this study is to evaluate the nature and quality of speech after removal of the voice box and all or part of the swallowing tube.
The study is evaluating which type of surgery provides patients with the best speech and voice.
These data will be used to help surgeons to design better ways to restore voice function after removal of the voice box. Information about disease, its treatment, quality of life, and physical and vocal function will be collected. An audio recording of vocal tasks will also be done. All of this information will be analyzed and the two different subject groups will be compared to see if there are differences.
|Condition or disease||Intervention/treatment|
|Larynx Cancer||Behavioral: questionnaires and standardized, digital voice recording|
|Study Type :||Observational|
|Actual Enrollment :||5 participants|
|Official Title:||Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Reconstruction Approaches|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Patients undergoing laryngectomy and pharyngeal reconstruction
Behavioral: questionnaires and standardized, digital voice recording
Patient will be asked to complete four sets of forms. Upon completion of these forms, the study subject and the investigator will proceed to a quiet room for the standardized, digital voice recording. Recording will be made on digital audiotape using a standardized portable, digital audio recorder.
- Determine the pertinent differences in objective and subjective voice parameters between PR techniques, specifically comparing those techniques that provide mucosal lining (jejunum) to those with cutaneous lining (radial forearm flap). [ Time Frame: conclusion of study ]
- Provide physician with meaningful and relevant data upon which to base the optimal choice of pharyngeal reconstruction method for individual patients who must undergo laryngectomy with pharyngeal reconstruction for the treatment of carcinoma. [ Time Frame: conclusion of study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600223
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Dennis Kraus, MD||Memorial Sloan Kettering Cancer Center|