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NCT05497947 Clinical Trial

Evaluation of the French Translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) After Total PharyngoLaryngectomy

Swallowing Disorder Clinical Trial

— SOAL-VF  

Official title:
Evaluation of the French Translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) After Total PharyngoLaryngectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05497947
Other study ID # 0007
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 3, 2021
Est. completion date July 3, 2023

Study information
Verified date August 2023
Source Centre Hospitalier de Valence
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A monocentric study to evaluate the french translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) after Total PharyngoLaryngectomy

Description:

the SOAL questionnaire is a validated Patient Reported Outcomes (PRO) questionnaire in English language. The aim of this study is to develop a new tool in french language and to evaluate incidence and the specific impact of swallowing disorders on the quality of life of patients after Total PharyngoLaryngectomy.

Recruitment information / eligibility
Status Completed
Enrollment 225
Est. completion date July 3, 2023
Est. primary completion date July 5, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Total PharyngoLaryngectomy - Age = 18 years old - Read, write and understand the French language Exclusion Criteria: - Patient under guardianship, deprived of liberty, safeguard of justice - Refusal to participate in research

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Ch Valence Valence Drome

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier de Valence

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary SOAL- VF Patient reported outcome measure up to 6 months
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