CancerREXORNCT05255315
Impact of Forearm Free Flap in Orbital Exenteration Reconstruction
An observational study of Cancer, run by Institut Curie at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer
- What is being tested?
- 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.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 10 Nov 2021to 10 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Legally protected patients
- Patients unable to give consent.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Curie
Paris, 75005
Antoine DUBRAY-VAUTRIN, MD, +33144324535, Antoine.DubrayVautrin@curie.fr
Adeline GIGANTI, Ph.D, +33147112355, adeline.giganti@curie.fr
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- 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.
- Keywords
- Forearm free flap, Orbital exenteration, Temporalis muscle flap, Quality of life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.Behavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start10 Nov 2021
- Primary completion10 Nov 2022 (estimated)
- Study completion10 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine DUBRAY-VAUTRIN, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255315
- Sponsor's protocol ID
- IC-2020-19
- Acronym
- REXOR
- Status last verified
- Feb 2022
- First submitted
- 14 Feb 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apport du Lambeau Libre antébrachial Dans la Reconstruction Post-exentération
- ClinicalTrials.gov ID
- NCT05255315
- Acronym / sponsor ID
- REXOR / IC-2020-19
- Conditions
- Cancer
- Keywords
- Forearm free flap, Orbital exenteration, Temporalis muscle flap, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 10 Nov 2022 (estimated)
- Study completion
- 10 Nov 2022 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Legally protected patients
- Patients unable to give consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | – |
Primary outcome
Temporal muscle flap patient questionnaire.
Time frame: Baseline
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)
Antebrachial flap patient questionnaire
Time frame: Baseline
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine DUBRAY-VAUTRIN, MD principal investigator
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoine DUBRAY-VAUTRIN, MD (+33144324535, Antoine.DubrayVautrin@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporal muscle flap patient questionnaire. (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.