NCT04994730

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 118 (estimated)
• Sponsor: Institut Curie · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

It is now obvious to all surgeons involved in the follow-up of these patients that not all orbital reconstruction techniques are equal. Thus, through this study, The investigators wish to objectively highlight the gain in quality of life and prosthetic equipment in exentered patients, depending on the reconstruction method used. This prospective study, including all patients who have been exentered at the Institut Curie Paris, from January 2004 to December 2019, proposes to compare the reported quality of life of patients according to the reconstruction technique patients have undergone. The investigators 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. The investigators will submit them, after express telephone agreement, by post to all the patients included in our study. The aim of such a study will therefore be to provide assistance to both surgeons and patients in the choice of an orbital reconstruction technique, by objectively demonstrating the superiority of one technique over the others in terms of quality of life and prosthetic equipment rate. The patients included in this study will have to answer two questionnaires, submitted by post. This study therefore falls within the framework of minimal or moderate risk studies. The patients will be informed by telephone interview about the method of writing the questionnaires and their content. The investigators will pay particular attention to the quality of life of the patients who have benefited from a free ante-brachial flap reconstruction in comparison with other reconstruction techniques; this will constitute the main criterion of our study. In addition, the collection of pseudo-anonymised computerised data from all the patient files will give rise to a comparison of post-operative healing times, the rate of prosthetic fitting, and the time taken to fit the prosthesis according to the reconstruction techniques. These three factors, already identified in the literature as indicators of good rehabilitationn , will constitute our secondary judgment criteria.

Conditions

• Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-25
• Primary completion: 2022-05-25
• Completion: 2022-05-25
• First posted: 2021-08-06
• Last updated: 2021-08-31

Locations

1 site across 1 country: France