Clinical trial NCT04994730: Exenteration: Quality of Life Study and Rehabilitation Rate According to the Reconstruction Technique (ETRE)
Official title: Exenteration: Quality of Life Study and Rehabilitation Rate According to the Reconstruction Technique
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Exenteration
Surgery
Quality of life
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients, living or lost, exentered at the Institut Curie Paris between January 2014 and December 2019,

Brief 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.

Eligibility criteria: Inclusion Criteria:

All patients, living or lost, exentered at the Institut Curie Paris between January 2014 and December 2019,

Exclusion Criteria:

* Persons under court protection.
* Persons not in a condition to give their consent.

Primary outcomes:
measure: Functional Assessment of Cancer Therapy: General (FACT-G)
timeFrame: Baseline
measure: FACT/McGill Body Image Concern Scale - Head and Neck Cancer Version (FACT-MBIS)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
affiliation: Institut Curie
name: Nathalie BADOIS, MD
role: PRINCIPAL_INVESTIGATOR
References: