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

Cancer Clinical Trial

— ETRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994730
• Other study ID #: IC 2020-14
• Status: Recruiting
• Start date: May 25, 2021
• Est. completion date: May 25, 2022

Study information

• Verified date: August 2021
• Source: Institut Curie
• Contact: Nathalie BADOIS, MD
• Phone: +33144324535
• Email: nathalie.badois[@]curie.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: May 25, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
France	Institut Curie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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