Impact of Forearm Free Flap in Orbital Exenteration Reconstruction (REXOR)

Apport du Lambeau Libre antébrachial Dans la Reconstruction Post-exentération

Orbital exenteration is the en bloc removal of the entire orbital contents. This mutilating surgical technique is reserved for the management of certain malignant orbito-palpebral tumors or those that secondarily invade the orbit.

Several types of exenteration have been described, more or less extended to the adjacent structures, with sometimes mixed ENT-neurosurgical approaches for lesions invading the endocranium and causing large losses of substance.

Different surgical reconstruction techniques have been developed over the years, from spontaneous epithelialization to free osteo-muscular flap and temporal muscle transpositions.

Reconstruction after exenteration is essential to limit the sequelae and to allow the patient who has undergone this trauma to regain social interactions, a quality of life and an optimal self-image.

The use of an antebrachial free flap would allow a faster healing and thus an earlier rehabilitation.

The main objective of the study was to compare the morbidity of the antebrachial free flap with that of the temporal flap during exenteration and the rate of fitting of patients with epitheses.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Comparative analysis comparing the morbidity of the antebrachial free flap to that of the temporal flap flap during exenteration as well as the rate of fitting patients with epithesis.

Detailed Description

Reconstruction after exenteration is essential to limit the after-effects and to allow the patient who has suffered this trauma to regain social interaction, quality of life and self-image.

The principal investigator hypothesize that reconstruction with a free antebrachial flap can improve the quality of life of an exentered patient while maintaining a low risk of intra- and post-operative morbidity.

The aim of such a study will therefore be to provide assistance to both surgeons and patients, as to the choice of the technique of orbital reconstruction, by highlighting objectively and subjective evidence of the benefits of one technique over the other.

The patients included in this study will have to answer two questionnaires, submitted by post or directly at the follow-up consultation. This study therefore falls within the framework of studies of minimal or moderate risk studies. They will be informed by telephone interview beforehand or directly in the consultation about the method of writing the questionnaires and their content.

• Study Type: Observational
• Enrollment (Anticipated): 72

Contacts and Locations

• Study Contact: Name: Antoine DUBRAY-VAUTRIN, MD; Phone Number: +33144324535; Email: Antoine.DubrayVautrin@curie.fr

Study Locations

• France
  • Paris, France, 75005
    • Recruiting
    • Institut Curie
    • Contact: Adeline GIGANTI, Ph.D; Phone Number: +33147112355; Email: adeline.giganti@curie.fr
    • Contact: Antoine DUBRAY-VAUTRIN, MD; Phone Number: +33144324535; Email: Antoine.DubrayVautrin@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 who were exentered and then reconstructed by free antebrachial flap or temporal muscle flap muscle flap at the Institut Curie Paris, between January 2005 and December 2020.

Description

Inclusion Criteria:

• Patients who were exentered and then reconstructed by free antebrachial flap or temporal muscle flap muscle flap at the Institut Curie Paris, between January 2005 and December 2020.

Exclusion Criteria:

• Legally protected patients
• Patients unable to give consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temporal muscle flap patient questionnaire.	A questionnaire of quality of life and side effects related to surgery for patients having a temporal muscle flap reconstruction (13 questions with binary or numerical answers)	Baseline
Antebrachial flap patient questionnaire	A questionnaire of quality of life and side effects related to surgery for patients having antebrachial flap reconstruction (17 questions with binary or numerical answers)	Baseline

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Principal Investigator: Antoine DUBRAY-VAUTRIN, MD, Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2021
• Primary Completion (Anticipated): November 10, 2022
• Study Completion (Anticipated): November 10, 2022

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; Forearm free flap; Orbital exenteration; Temporalis muscle flap
• Other Study ID Numbers: IC-2020-19

Drug and device information, study documents

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