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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

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.

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.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

October 2010

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Dennis Kraus, MD		krausd@mskcc.org
Contact: Ryan Branski, PhD		branskir@mskcc.org

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 ^††

Massachusetts Eye and Ear Infirmary
Brigham and Women's Hospital

Investigators ^†

Principal Investigator:

Dennis Kraus, MD

Memorial Sloan-Kettering Cancer Center

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.