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Clinical Trials/NL-OMON50065
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational non invasive

Investigators

Sponsor
Antoni van Leeuwenhoek Ziekenhuis

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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