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Clinical Trials/NCT00600223
NCT00600223
Completed
Not Applicable

Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Reconstruction Approaches

Memorial Sloan Kettering Cancer Center1 site in 1 country5 target enrollmentOctober 2005
ConditionsLarynx Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Larynx Cancer
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
5
Locations
1
Primary Endpoint
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).
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
October 2010
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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.(conclusion of study)

Study Sites (1)

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