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

  • STATUS
    Recruiting
  • days left to enroll
    4
  • participants needed
    118
  • sponsor
    Institut Curie
Updated on 6 September 2021

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.

Details
Condition Cancer, Neoplasms, primary cancer, malignancy, primary malignant neoplasm, cancer of the head and neck, cancers, malignant tumor, Ewing's Family Tumors, malignancies, malignant tumors, Cancer/Tumors, Cancer (Pediatric), Head and Neck Cancer, head and neck cancer
Treatment Quality of life according to the reconstruction technique
Clinical Study IdentifierNCT04994730
SponsorInstitut Curie
Last Modified on6 September 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note