Clinical Research Directory

Comparison of Mastectomy Expander Trial

Expanders are used outside their intended use, due to two following facts: It is possible that expander implantation exceed the "approved" duration of 6 months (maximal 10 months). Additionally, some participants will receive after mastectomy/expander implantation an adjuvant radiotherapy according to standard of care, which is either a contraindication of the medical device or not yet tested in-vivo by the manufacturer. Requested answers: * how good is the aesthetic outcome of the breast with the expanders and the final implants, and whether any complications occurred during treatment, * how satisfied are subjects and doctors with the outcome of the breast reconstruction, and how the reconstruction affects health-related quality of life from participants, * how does the structural composition of the removed expanders looks like, in order to understand whether radiation therapy has caused changes in the material, * which key immunological factors lead to increased hardening of the tissue around the expander, especially during radiation therapy (capsule formation).

The TEAM Long-Term Cohort Study (A Sub-study of TEAM(III))

This study is a prospective cohort study to evaluate the long-term effects of early activity and mobilisation compared to standard care on disability, function and health status for patients at 1, 2 and 5 years after recruitment of patients randomised into the TEAM Phase III RCT (ClinicalTrials.gov NCT03133377). The primary outcome of the study will be the level of disability as measured by the World Health Organisation's Disability Schedule 2.0, 12 level (WHODAS) at 2 years after recruitment.