Speech and Swallowing Characteristics of Patients After Laryngectomy and the Effect on Quality of Life
1 other identifier
observational
40
0 countries
N/A
Brief Summary
Swallowing and speech difficulties will be observed in patients post laryngectomy. These difficulties will cause decreased in quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2012
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2012
CompletedFirst Posted
Study publicly available on registry
May 28, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 28, 2012
May 1, 2012
1 year
May 24, 2012
May 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Speech and swallowing characteristics of patients post laryngectomy
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.
At the completion of data collection -1 year
Secondary Outcomes (1)
The relationship between speech and swallowing disturbances of patients post laryngectomy
1 year at the completion of data collection
Study Arms (1)
Total laryngectomy
A group of patients who underwent total laryngectomy with trechea esophageal puncture (TEP)
Eligibility Criteria
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.
You may qualify if:
- patients post total laryngectomy with voice prothesis
You may not qualify if:
- patients who can not read and respod to questions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
* Maclean, J., Cotton, S., & Perry, A. (2009). Post-laryngectomy: it's hard to swallow: an Australian study of prevalence and self-reports of swallowing function after a total laryngectomy. Dysphagia, 24(2), 172-179. * Maclean, J., Cotton, S., & Perry, A. (2009). Dysphagia following a total laryngectomy: the effect on quality of life, functioning, and psychological well-being. Dysphagia, 24(3), 314-321. * McHorney, C. A., Robbins, J., Lomax, K., Rosenbek, J. C., Chignell, K., Kramer, A. E., & Bricker, D. E. (2002). The SWAL-QOL and SWAL-CARE outcomes tool for oropharyngeal dysphagia in adults: III. Documentation of reliability and validity. Dysphagia, 17(2), 97-114. * Platteaux, N., Dirix, P., Dejaeger, E., & Nuyts, S. (2010). Dysphagia in head and neck cancer patients treated with chemoradiotherapy. Dysphagia, 25(2), 139-152. * Kapila,M., Deore,N., Palav,R.S., Kazi,R.A., Shah,R.P., & Jagade,M.V.(2011). A brief review of voice restoration following total laryngectomy. Indian Journal of Cancer,48(1),99-104. * Rizzo,B.p.,Maronato,F.,Marchiori,C., Gava,A., &Da Mosto, M,C.(2008). Long-Term Quality of Life After Total Laryngectomy and Postoperative Radiotherapy Versus Concurrent Chemoradiotherapy for Laryngeal Preservation. The Laryngoscope.118,300-306 (2010). Total Laryngectomy.OtorhinolaryngologyMohebati,A. Mohebati,A & * Shah ,p .j , International Journal, 2(3), pp 207-214
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob T Cohen, PhD
Tel Aviv Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2012
First Posted
May 28, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2013
Study Completion
December 1, 2014
Last Updated
May 28, 2012
Record last verified: 2012-05