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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00600223
Enrollment
5
Registered
2008-01-24
Start date
2005-10-31
Completion date
2010-10-31
Last updated
2010-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Larynx Cancer

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.

Interventions

BEHAVIORALquestionnaires 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.

Sponsors

Massachusetts Eye and Ear Infirmary
CollaboratorOTHER
Brigham and Women's Hospital
CollaboratorOTHER
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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).conclusion of study

Secondary

MeasureTime 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.conclusion of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026