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

Completed

• Conditions: Larynx Cancer
• Interventions: Behavioral: questionnaires and standardized, digital voice recording

• Registration Number: NCT00600223
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-11
• Study First Posted: 2008-01-24
• Status Verified: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Last Update Submitted: 2010-10-08
• Last Update Posted: 2010-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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Exclusion Criteria

• Do not have functional voice restoration.
• Do not speak English as a functional language.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	questionnaires and standardized, digital voice recording	Patients undergoing laryngectomy and pharyngeal reconstruction

Primary Outcome Measures

Name	Time	Method
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).	conclusion of study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States