NCT05255315

Impact of Forearm Free Flap in Orbital Exenteration Reconstruction

Apport du Lambeau Libre antébrachial Dans la Reconstruction Post-exentération

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 72 (estimated)
• Sponsor: Institut Curie · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Cancer

Interventions

Type	Name	Description
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.	A retrospective analysis will be performed by comparing the computerized data of patients reconstructed with a free antebrachial flap to that of patients reconstructed with a temporal muscle flap. Another analysis, this time prospective, will be carried out by comparing the answers to the reconstruction specific questionnaires as well as the POSAS scores of patients reconstructed with either a free antebrachial flap or a temporalis muscle flap.

Timeline

• Start date: 2021-11-10
• Primary completion: 2022-11-10
• Completion: 2022-11-10
• First posted: 2022-02-24
• Last updated: 2022-03-11

Locations

1 site across 1 country: France