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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Quality of life according to the reconstruction technique

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.

• Study Type: Observational
• Enrollment (Anticipated): 118

Contacts and Locations

• Study Contact: Name: Nathalie BADOIS, MD; Phone Number: +33144324535; Email: nathalie.badois@curie.fr

Study Locations

• France
  • Paris, France, 75005
    • Recruiting
    • Institut Curie
    • Contact: Nathalie BADOIS, MD; Phone Number: +33156245765; Email: nathalie.badois@curie.fr
    • Contact: Sandra NESPOULOUS; Phone Number: +33 147111654; Email: drci.promotion@curie.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Cancer Therapy: General (FACT-G)	The FACT-G questionnaire consists of 27 general items, with the patient scoring each item on a scale of 0 to 4. The final score is the sum of all the items.	Baseline
FACT/McGill Body Image Concern Scale - Head and Neck Cancer Version (FACT-MBIS)	The FACT-MBIS questionnaire consists of 21 items related to self-esteem and social comfort, each item is also scored on a scale of 0 to 4. The final score is the sum of all items.	Baseline

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Principal Investigator: Nathalie BADOIS, MD, Institut Curie

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 25, 2021
• Primary Completion (ANTICIPATED): May 25, 2022
• Study Completion (ANTICIPATED): May 25, 2022

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (ACTUAL): August 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Surgery; Quality of life; Exenteration
• Other Study ID Numbers: IC 2020-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No