Speech and Swallowing Characteristics of Patients After Laryngectomy and the Effect on Quality of Life
This study is not yet open for participant recruitment.
Verified May 2012 by Tel-Aviv Sourasky Medical Center
Sponsor:
Tel-Aviv Sourasky Medical Center
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
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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
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 May 19, 2013