280
Participants
Start Date
July 14, 2023
Primary Completion Date
September 30, 2027
Study Completion Date
June 30, 2036
Surgical Intervention
LVA (Lymphovenous Anastomosis) and VLNT (Vascularised Lymph Node Transfer) are two advanced microsurgical techniques that are increasingly implemented in clinical practice in specialized centers and that are already carried out after health insurance application according to local standard of care. They have been studied in their respective mode of action as well as in their effectiveness in treating chronic BCRL (Breast Cancer-Related Lymphedema) in a multitude of mostly observational and single center studies with highly encouraging results. Patients in the interventional arm A will receive surgery with one of the two approaches or a combination of both, in a one or two-stage method, at the discretion of the treating surgeon. Depending on local standards one or both of the above might be combined with liposuction to the affected arm in a one or two-stage approach as well.
Conservative Complex Physical Decongestion Therapy
Patients randomized to the control arm will receive CDT (Conservative Complex Physical Decongestion Therapy), which currently is considered as the best available standard of care. For this, patients will be referred to one of the dedicated LE (physical/skin) therapy clinics, if not already treated by one, according to their place of residence for continuation of standard conservative therapy. Recommendations to the procedures and treatment frequency of the conservative therapy will be made, but CDT will be done at the discretion of the treating physiotherapist.
RECRUITING
Centre Hospitalier Universitaire Vaudois, Lausanne
RECRUITING
Hôpitaux Universitaires de Genève, Geneva
RECRUITING
University Hospital Basel, Basel
RECRUITING
Kantonsspital Aarau, Aarau
NOT_YET_RECRUITING
Maastricht University Medical Center, Maastricht
RECRUITING
Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie, Zurich
RECRUITING
Kantonsspital Winterthur, Winterthur
RECRUITING
University of Ghent, Ghent
NOT_YET_RECRUITING
Memorial Sloan Kettering Cancer Center, New York
NOT_YET_RECRUITING
Karolinska Institutet, K1 Molekylär medicin och kirurgi, Stockholm
RECRUITING
Sana Kliniken Düsseldorf, Düsseldorf
RECRUITING
BG Universitätsklinikum Bergmannsheil Bochum, Bochum
RECRUITING
KEM Evang. Kliniken Essen-Mitte, Essen
RECRUITING
Papageorgiou Hospital of Thessaloniki, Thessaloniki
NOT_YET_RECRUITING
BG Klinik Frankfurt am Main, Frankfurt
RECRUITING
Washington University School of Medicine in St. Louis, St Louis
RECRUITING
BG Klinik Ludwigshafen, Ludwigshafen am Rhein
RECRUITING
Universitätsklinikum Freiburg, Klinik für Plastische und Handchirurgie, Freiburg im Breisgau
RECRUITING
Uniklinikum Erlangen, Erlangen
RECRUITING
Caritas Krankenhaus St. Josef/ Uniklinik Regensburg, Regensburg
RECRUITING
Institute of Oncology ''Prof. Dr. Ion Chiricuță'' of Cluj-Napoca, Cluj-Napoca
NOT_YET_RECRUITING
Rambam Health Clinic, ISR, Haifa
NOT_YET_RECRUITING
Harvard Medical School, Boston
NOT_YET_RECRUITING
Hospital Erasto Gaertner, Paraná
NOT_YET_RECRUITING
McGill University, Royal Victoria Hospital, Montreal
RECRUITING
University of British Columbia, Gordon and Leslie Diamond Health Care Centre, Vancouver
NOT_YET_RECRUITING
Plastic and Reconstructive Surgery at Department of Surgical Science, Rome
RECRUITING
Policlinic Gemelli, Operational Unit of Plastic Surgery, Rome
NOT_YET_RECRUITING
Hospital de la Santa Creu i Sant Pau, Barcelona
RECRUITING
Department of Plastic and Reconstructive Surgery Uppsala University Hospital, Uppsala
Swiss National Science Foundation
OTHER
Rising Tide Foundation
OTHER
Krebsforschung Schweiz, Bern, Switzerland
OTHER
University Hospital, Basel, Switzerland
OTHER