NL-OMON50065
Completed
Not Applicable
Improved implant for reconstruction purposes after mandibular resection - RIfRaM
Antoni van Leeuwenhoek Ziekenhuis0 sites10 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 10
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>\= 18 years at time of study entry.
- •T4 oral cavity tumor with mandible invasion, requiring segmental
- •mandibulectomy.
- •Reconstruction with free fibula flap not feasible because of any or a
- •combination of the following reasons::
- •o CT angiography of the legs and/or the neck shows severe stenosis of the
- •o Previous medical history of severe atherosclerotic disease.
- •o General health condition necessitating a shorter operation time.
- •Cases will be discussed in the multidisciplinary tumor board that they are
- •eligible for composite resection but not eligible for free fibula flap.
Exclusion Criteria
- •Patients who are eligible for free fibula flap.
- •Pregnancy.
- •General health condition does not allow surgery
- •History of psychiatric disability judged by the investigator to potentially
- •hamper compliance with the study protocol and follow\-up schedule.
- •Any psychological, familial, sociological or geographical condition
- •potentially hampering compliance with the study protocol and follow\-up
Outcomes
Primary Outcomes
Not specified
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