Informations générales (source: ClinicalTrials.gov)
PREvention of Post-mastectomy LYMphoceles by PAdding. A Randomized Prospective Multicenter Study (PRELYMCA)
Interventional
N/A
Centre Hospitalier Universitaire, Amiens (Voir sur ClinicalTrials)
mai 2013
août 2017
29 juin 2024
Lymphoceles, or seromas, are the most frequent complication following mastectomy and are
associated or not with axillary dissection occurring in 10 to 90% of cases. It is defined
as the presence of a palpable post operative serous accumulation that is bothersome for
the patient and requires a puncture and drainage or even several repeated punctures. The
presence of seromas is therefore associated with discomfort and pain. Seromas could also
be responsible for increased morbidity due to complications such as infection, suture
separating, lymphedema, prolonged of hospital stay, or a delay in initiation of adjunct
treatment (e.g. chemotherapy, radiotherapy). Some risk factors have been identified, such
as obesity, increased post operative drainage of J1 to J3, and arterial hypertension.
Different measures have demonstrated the benefits of limiting axillary lymphoceles after
dissection : placement of a drain, padding and delay in shoulder mobility.
Studies have shown that axillary padding decreases lymphocele development and shortens
the length of hospital stay. Some studies based on padding of the mastectomy site also
have shown a decrease in post operative seromas; however no study has been done on the
usefulness of padding in the mastectomy site alone because they include both padding and
a drain or padding of the axillary area.
The padding technique the investigators employ is performed at the donor site in breast
reconstruction by latissimus dorsi muscle flap, demonstrating a reduction in the rate of
seromas.
In this study, the classic technique will be compared to padding in the mastectomy site
with short drainage (48h).
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH Compiègne - 60321 - Compiegne - France | Johanna MYCHALUK, MD | Contact (sur clinicalTrials) | |||
| CH Soissons - 02209 - Soissons - France | Pascal ABBOUD, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Amiens - 80054 - Amiens - France | Mohamed AIT AMER MEZIANE, PhD | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- Age ≥ 18 years
- Female gender
- Patients with infiltrating or in situ breast cancer
- Indication of surgical treatment by mastectomy
- Patient providing written informed consent
- Patient with health insurance coverage
- Ability to provide voluntary written informed consent
- Age ≥ 18 years
- Female gender
- Patients with infiltrating or in situ breast cancer
- Indication of surgical treatment by mastectomy
- Patient providing written informed consent
- Patient with health insurance coverage
- Ability to provide voluntary written informed consent
- Informed consent cannot be obtain
- Pregnant or lactating women
- Patients undergoing immediate breast reconstruction
- Patients with cancer untreatable by mastectomy, non curative mastectomy: partial
mastectomies, preventive mastectomies (BRCA genetic mutations)
- Patients under legal protection or unable to come to a center
- Patients unable to express voluntary consent
- Patients receiving post operative anticoagulants or platelet antiaggregants
- Patients requiring postoperative anticoagulants
- Bilateral mastectomy