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Exenteration: Quality of Life Study and Rehabilitation Rate According to the Reconstruction Technique (ETRE)

NCT04994730 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 118

Last updated 2021-08-31

No results posted yet for this study

Summary

Prospective monocentric quality of life study. Including all patients who have been exentered at the Institut Curie Paris, from January 2004 to December 2019, proposing to compare the reported quality of life of patients according to the reconstruction technique they have undergone.

The sponsor will evaluate the quality of life of our patients by means of two validated questionnaires, in French, in the context of ENT surgery: the FACT-G and FACT-MBIS questionnaires.

Conditions

Interventions

BEHAVIORAL

Quality of life according to the reconstruction technique

For this retrospective analysis, 118 patients could be included, 17 of whom had undergone ante-brachial free flap reconstruction, 16 of whom had undergone this reconstruction within the last 2 years. The primary endpoint: Analysis of the quality of life score according to the reconstruction technique (free ante-brachial flap versus others) will be performed by a Wilcoxon-Mann-Whitney test.

Sponsors & Collaborators

  • Institut Curie

    lead OTHER

Principal Investigators

  • Nathalie BADOIS, MD · Institut Curie

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2022-05-25
Completion
2022-05-25

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04994730 on ClinicalTrials.gov