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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 reconstruction

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 reconstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025841
Enrollment
100
Registered
2021-07-15
Start date
2022-10-24
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C01 C02 C03 C04 C05 C06 C44 C40 C41 C07 C08 C09 C10 C11 C12 C13 C14

Interventions

Group 1: Patients with microvascular flap transplant - Patients evaluation of Quality of Life (Questionaire), evaluation of hospitalization duration, evaluation of post-surgery and other complications

Sponsors

Universitätsklinikum derGoethe-Universität Frankfurt am MainKlinik für Mund-, Kiefer- und Plastische Gesichtschirurgie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Dependency of the therapy outcome (regain of continuity and functionality of oral cavity and facial structures) and quality of life on reconstruction type

Secondary

MeasureTime frame
- occurrence of post-surgery complications (e.g. infection) and duration of hospitalization - dependency of post-surgery wound healing on vitamin D level - non-invasive evaluation of functionality of Musculus Quadriceps femoris (transplant donor site) pre- and post-surgery

Countries

Germany

Contacts

Public ContactAnna Daffner

Universitätsklinikum derGoethe-Universität Frankfurt am MainKlinik für Mund-, Kiefer- und Plastische Gesichtschirurgie

Study-Unit-MKPG@kgu.de+49-69-6301-4492

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026