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Impact of Forearm Free Flap in Orbital Exenteration Reconstruction

NCT05255315 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2022-03-11

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Institut Curie

    lead OTHER

Principal Investigators

  • Antoine DUBRAY-VAUTRIN, MD · Institut Curie

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-10
Primary Completion
2022-11-10
Completion
2022-11-10

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05255315 on ClinicalTrials.gov