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
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 24, 2012 | ||||||||
| Last Updated Date | May 25, 2012 | ||||||||
| Start Date ICMJE | June 2012 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01607138 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Speech and Swallowing Characteristics of Patients After Laryngectomy and the Effect on Quality of Life | ||||||||
| Official Title ICMJE | Speech and Swallowing Characteristics of Patients After Laryngectomy and the Effect on Quality of Life | ||||||||
| Brief Summary | Swallowing and speech difficulties will be observed in patients post laryngectomy. These difficulties will cause decreased in quality of life. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. |
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| Condition ICMJE | Cancer of the Larynx | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Total laryngectomy
A group of patients who underwent total laryngectomy with trechea esophageal puncture (TEP) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | December 2014 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 35 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Not Provided | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01607138 | ||||||||
| Other Study ID Numbers ICMJE | TASMC-12-CTJ-224-CTIL | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Tel-Aviv Sourasky Medical Center | ||||||||
| Study Sponsor ICMJE | Tel-Aviv Sourasky Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Tel-Aviv Sourasky Medical Center | ||||||||
| Verification Date | May 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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