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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
First received: May 24, 2012
Last updated: May 25, 2012
Last verified: May 2012
Swallowing and speech difficulties will be observed in patients post laryngectomy. These difficulties will cause decreased in quality of life.

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)
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.

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.

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

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
Principal Investigator: Jacob T Cohen, PhD Tel Aviv Medical Center
  More Information

* Maclean, J., Cotton, S., & Perry, A. (2009). Post-laryngectomy: itʼs 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

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:
swallowing disturbances
speech disturbances
speech intelligibility
voice prothesis

ClinicalTrials.gov processed this record on February 11, 2016