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Tracking Information | |||||||||
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First Received Date † | January 11, 2008 | ||||||||
Last Updated Date | January 8, 2009 | ||||||||
Start Date † | October 2005 | ||||||||
Current Primary Outcome Measures † |
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 ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00600223 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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 ] [ Designated as safety issue: No ] | ||||||||
Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Construction Approaches | ||||||||
Official Title † | Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Reconstruction Approaches | ||||||||
Brief Summary | 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. |
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Detailed Description | |||||||||
Study Phase | |||||||||
Study Type † | Observational | ||||||||
Study Design † | Cohort, Prospective | ||||||||
Condition † | Larynx Cancer | ||||||||
Intervention † | Behavioral: questionnaires and standardized, digital voice recording | ||||||||
Study Arms / Comparison Groups | Patients undergoing laryngectomy and pharyngeal reconstruction | ||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Estimated Enrollment † | 20 | ||||||||
Estimated Completion Date | October 2010 | ||||||||
Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00600223 | ||||||||
Responsible Party | Dennis Kraus, MD, Memorial Sloan-Kettering Cancer Center | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Memorial Sloan-Kettering Cancer Center | ||||||||
Collaborators †† |
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Investigators † |
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Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||||||
Verification Date | January 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |