RESUMEN
INTRODUCTION: Lymphoedema is a chronic condition caused by lymphatic insufficiency. It leads to swelling of the limb/midline region and an increased risk of infection. Lymphoedema is often associated with mental and physical problems limiting quality of life. The first choice of treatment is a conservative treatment, consisting of exercises, skin care, lymph drainage and compression. Reconstructive lymphatic surgery is also often performed, that is, lymphovenous anastomoses, lymph node transfer or a combination. However, robust evidence on the effectiveness of reconstructive lymphatic surgery is missing. Therefore, the objective of this trial is to investigate the added value of reconstructive lymphatic surgery to the conservative treatment in patients with lymphoedema. METHODS AND ANALYSIS: A multicentre randomised controlled and pragmatic trial was started in March 2022 in three Belgian university hospitals. 90 patients with arm lymphoedema and 90 patients with leg lymphoedema will be included. All patients are randomised between conservative treatment alone (control group) or conservative treatment with reconstructive lymphatic surgery (intervention group). Assessments are performed at baseline and at 1, 3, 6, 12, 18, 24 and 36 months. The primary outcome is lymphoedema-specific quality of life at 18 months. Key secondary outcomes are limb volume and duration of wearing the compression garment at 18 months. The approach of reconstructive lymphatic surgery is based on presurgical investigations including clinical examination, lymphofluoroscopy, lymphoscintigraphy, lymph MRI or CT angiography (if needed). All patients receive conservative treatment during 36 months, which is applied by the patient's own physical therapist and by the patient self. From months 7 to 12, the hours a day of wearing the compression garment are gradually decreased. ETHICS AND DISSEMINATION: The study has been approved by the ethical committees of University Hospitals Leuven, Ghent University Hospital and CHU UCL Namur. Results will be disseminated via peer-reviewed journals and presentations. TRIAL REGISTRATION NUMBER: NCT05064176.
Asunto(s)
Linfedema , Calidad de Vida , Humanos , Bélgica , Pierna , Linfedema/terapia , Linfedema/cirugía , Estudios Multicéntricos como Asunto , Procedimientos de Cirugía Plástica/métodos , Ensayos Clínicos Pragmáticos como AsuntoRESUMEN
OBJECTIVE: The purpose of this study was to assess the oncologic safety of mastectomies associated with immediate breast reconstruction (IBR) in terms of recurrence and survival. METHODS: A retrospective review was conducted at a single center (CHU UCL Namur, Belgium). We analyzed the oncologic safety of IBR for patients with invasive and in situ breast cancer who underwent mastectomy associated with IBR. Patients who underwent palliative surgery and those with a diagnosis of breast sarcoma were excluded. RESULTS: We retrospectively analyzed 138 patients who underwent mastectomy and IBR between January 2012 and December 2019. Most reconstruction procedures used deep inferior epigastric perforator free flaps (55.1%). The reconstructive failure rate was 8.7%. Among the patients included, 5 cases of local cancer recurrence, 1 case of local cancer recurrence associated with distant metastasis, and 2 cases of systemic recurrence were identified during a mean follow-up of 49.3 months (range, 8-104 months) after surgery. Overall survival was 97.8%, and disease-free survival was 94.2%. CONCLUSIONS: Patients had a low incidence of cancer recurrence in this review. Immediate breast reconstruction after mastectomy had no negative impact on recurrence or patient survival, even in patients with advanced disease. The study findings suggest that mastectomy associated with IBR can be a safe surgical option for patients with invasive and noninvasive breast cancers. Longer follow-ups are needed to confirm these preliminary results.
Asunto(s)
Neoplasias de la Mama , Mamoplastia , Neoplasias de la Mama/cirugía , Femenino , Humanos , Mastectomía , Recurrencia Local de Neoplasia/epidemiología , Recurrencia Local de Neoplasia/cirugía , Estudios RetrospectivosRESUMEN
Vacuum-assisted closure (V.A.C.) was used in two paraplegic patients with Fournier's gangrene in a context of ischial pressure ulcer This type of dressing facilitated preparation of reconstruction.