Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Construction Approaches
October 8, 2010 updated by: Memorial Sloan Kettering Cancer Center
Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Reconstruction Approaches
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
MSKCC clinic
Description
Inclusion Criteria:
- Subjects who have undergone removal of the larynx and the entire pharynx by either traditional reconstruction or more advanced reconstructive techniques, which involve the use of tissue, such as skin or bowel, from other parts of the body. There is no time frame for reconstruction. All subjects who have previously undergone reconstruction are eligible.
- Subjects who use the tracheoesophageal puncture method of voice restoration as their primary communication technique.
- > or equal to 18 years old
Exclusion Criteria:
- Do not have functional voice restoration.
- Do not speak English as a functional language.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Patients undergoing laryngectomy and pharyngeal reconstruction
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
conclusion of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
conclusion of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dennis Kraus, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
January 11, 2008
First Submitted That Met QC Criteria
January 11, 2008
First Posted (Estimate)
January 24, 2008
Study Record Updates
Last Update Posted (Estimate)
October 11, 2010
Last Update Submitted That Met QC Criteria
October 8, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.