Clinical observational study for evaluation of the therapy outcome and the dependency of the outcome on parameters as reconstruction type and/or vitamin D level in OMS tumor patients in need of intra-oral tumor resection and reconstructio
Recruiting
- Conditions
- C01C02C03C04C05C06C44C40C41C07
- Registration Number
- DRKS00025841
- Lead Sponsor
- niversitätsklinikum derGoethe-Universität Frankfurt am MainKlinik für Mund-, Kiefer- und Plastische Gesichtschirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
patients with indication for extended tumor resection in head-neck-area w/wo reconstruction with microvascular flap transplants
- patients in tumor therapy or in post-therapy follow-up
- age 18 years and older
- patients, which are able and willing to follow usual therapy related instructions (e.g. follow-up visits)
- informed consent of prospective patients
Exclusion Criteria
- pathological increased serological vitamin D level
- juvenile patients and/or vulnerable patients
- systematic diseases with known influence on wound healing and vitamin D level
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dependency of the therapy outcome (regain of continuity and functionality of oral cavity and facial structures) and quality of life on reconstruction type<br><br>
- Secondary Outcome Measures
Name Time Method - occurrence of post-surgery complications (e.g. infection) and duration of hospitalization<br>- dependency of post-surgery wound healing on vitamin D level<br>- non-invasive evaluation of functionality of Musculus Quadriceps femoris (transplant donor site) pre- and post-surgery <br><br>