Functional Results of Soft Palate Free Flap Reconstruction
NCT ID: NCT03890783
Last Updated: 2020-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
29 participants
OBSERVATIONAL
2019-02-27
2020-03-11
Brief Summary
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The treatment of oropharyngeal tumors is based on primary surgery or radiotherapy, but tumors of the soft palate are often treated by radiotherapy or radio-chemotherapy first. Surgery is often kept for relapses, because it is considered to lead to important sequelae. However, chemoradiotherapy of the oropharynx is also responsible for acute toxicities, and late sequelae can be frequent and important.
Recent publications tend to show that primary surgery would give better survival rates compared to radiotherapy, particularly in advanced stages, including viro-induced cancers. In addition, primary surgery can reduce the dose of radiation delivered to the oropharynx and thus reduce its long-term toxicity.
It is currently possible to reconstruct a loss of substance after surgery of oropharyngeal cancers, including the soft palate by using free flaps, limiting the postoperative sequelae usually observed without reconstruction.
There is little data on reconstructions of the soft palate, their sequelae and their impact on the quality of life.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients after surgery of oropharyngeal cancers
Patients after surgery of oropharyngeal cancers with soft palate with free flap reconstruction and adjuvant radiotherapy
Evaluation of phonation quality
Evaluation of phonation quality by :
* Self-evaluation: completion of the Voice Handicap Index questionnaire, in its 30 items version
* Hetero-evaluation: reading and recording of 2 texts, and notation by 3 practitioners using the grade, rough, breathy, asthenic, strained (GRBAS) scale, to evaluate the occurrence and the gravity of rhinolalia
Evaluation of swallowing quality
Evaluation of swallowing quality by:
* Self-evaluation: completion of the Deglutition Handicap Index questionnaire
* Hetero-evaluation: nasofibroscopy to evaluate the occurrence of aspiration and nasal regurgitation
global quality of life questionnaire
Completion of the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ - C30) and the EORTC QLQ - H\&N35 questionnaires
Interventions
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Evaluation of phonation quality
Evaluation of phonation quality by :
* Self-evaluation: completion of the Voice Handicap Index questionnaire, in its 30 items version
* Hetero-evaluation: reading and recording of 2 texts, and notation by 3 practitioners using the grade, rough, breathy, asthenic, strained (GRBAS) scale, to evaluate the occurrence and the gravity of rhinolalia
Evaluation of swallowing quality
Evaluation of swallowing quality by:
* Self-evaluation: completion of the Deglutition Handicap Index questionnaire
* Hetero-evaluation: nasofibroscopy to evaluate the occurrence of aspiration and nasal regurgitation
global quality of life questionnaire
Completion of the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ - C30) and the EORTC QLQ - H\&N35 questionnaires
Eligibility Criteria
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Inclusion Criteria
* Patients over 18 years old
Exclusion Criteria
* Patients who expressed their opposition to participate to the study
* Patients who do not speak French (incompatible with reading, understanding and filling out the questionnaires)
* Patients participating in interventional research (excluding physiological studies and interventional research with minimal risks and constraints that do not interfere with the primary endpoint analysis)
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Groupement Hospitalier Lyon Nord - Hospices Civils de Lyon
Lyon, , France
Countries
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Other Identifiers
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2018-A03408-47
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL18_0826
Identifier Type: -
Identifier Source: org_study_id
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