Impact of Forearm Free Flap in Orbital Exenteration Reconstruction

NCT05255315 | Unknown

• 1 other identifier: IC-2020-19
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Cancer

Keywords

Forearm free flap; Orbital exenteration; Temporalis muscle flap; Quality of life

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

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. BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Legally protected patients
• Patients unable to give consent.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie

Paris, 75005, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Antoine DUBRAY-VAUTRIN, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine DUBRAY-VAUTRIN, MD

CONTACT

+33144324535; Antoine.DubrayVautrin@curie.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 24, 2022
• Study Start: November 10, 2021
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-02

Locations

FR (1)