Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05255315
Study type Observational
Source Institut Curie
Contact Antoine DUBRAY-VAUTRIN, MD
Phone +33144324535
Email Antoine.DubrayVautrin@curie.fr
Status Recruiting
Phase
Start date November 10, 2021
Completion date November 10, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients