Speech and Swallowing Characteristics of Patients After Laryngectomy and the Effect on Quality of Life

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2012 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01607138
First received: May 24, 2012
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

Swallowing and speech difficulties will be observed in patients post laryngectomy. These difficulties will cause decreased in quality of life.


Condition
Cancer of the Larynx

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Speech and Swallowing Characteristics of Patients After Laryngectomy and the Effect on Quality of Life

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Speech and swallowing characteristics of patients post laryngectomy [ Time Frame: At the completion of data collection -1 year ] [ Designated as safety issue: No ]
    After recording the patients' speech the speech characteristics will be analysed according to specific parameters. Also after performing swallowing eveluation swallowing disturbances will be diagnosed and described.


Secondary Outcome Measures:
  • The relationship between speech and swallowing disturbances of patients post laryngectomy [ Time Frame: 1 year at the completion of data collection ] [ Designated as safety issue: No ]
    After analyzing the speech and swallowing disturbances of patients post laryngectomy, the relationship between these variables will be examined.


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Total laryngectomy
A group of patients who underwent total laryngectomy with trechea esophageal puncture (TEP)

Detailed Description:

This study will explore the characteristics of speech and swallowing problems of patients who underwent laryngectomy.The relationship between swallowing disturbances and speech difficulties will be studied and the effect of each problem on quality of life will be messured.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

40 adult patients, ages 35-80 y/o who underwent total laryngectomy and a trechea esophageal puncture was performed for the use of voice prothesis.

Criteria

Inclusion Criteria:

  • patients post total laryngectomy with voice prothesis

Exclusion Criteria:

  • patients who can not read and respod to questions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607138

Contacts
Contact: Jacob T Cohen, MD 0524266364 jacobc@tasmc.health.gov.il
Contact: Yael Manor, PhD 0524266942 yaelm@tasmc.health.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Jacob T Cohen, PhD Tel Aviv Medical Center
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01607138     History of Changes
Other Study ID Numbers: TASMC-12-CTJ-224-CTIL
Study First Received: May 24, 2012
Last Updated: May 25, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
laryngectomy
swallowing disturbances
speech disturbances
speech intelligibility
voice prothesis

Additional relevant MeSH terms:
Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014