Evaluation du curage axillaire dans le cancer du sein par capitonnage aponévrotique sans drainage

LE KREMLIN-B.- PARIS 11-BU Méd (940432101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

Comparison of the Explantation Rate of Poly Implant Prothèse, Allergan, and Pérouse Silicone Breast Implants within the First Four Years after Reconstructive Surgery before the Poly Implant Prothèse Alert by the French Regulatory Authority

Background. In March 2010, ANSM (Agence Nationale de Sécurité du Medicament), the French Medical Regulatory Authority, withdrew Poly Implant Prothèse (PIP) breast implants from the market due to the use of non-medical-grade silicone gel. The aim of this study was to compare the removal rate (and reasons thereof) of breast implants produced by different manufacturers before the ANSM alert. Materials and Methods. From October 2006 to January 2010, 652 women received 944 implants after breast cancer surgery at the Gustave Roussy Comprehensive Cancer Center, Paris (France). The complications and removal rates of the different implant brands used (PIP, Allergan, and Pérouse) were evaluated and compared. Results. PIP implants represented 50.6% of the used implants, Allergan 33.4%, and Pérouse 16%. The main reasons for implant removal were patient dissatisfaction due to aesthetic problems (43.2%), infection (22.2%), and capsular contracture (13.6%). Two years after implantation, 82% of Pérouse implants, 79% of PIP, and 79% of Allergan were still in situ. There was no difference in removal rate among implant brands. Conclusion. Before the ANSM alert concerning the higher rupture rate of PIP breast implants, our implant removal rate did not predict PIP implant failure related to the use of nonapproved silicone gel

Evaluation of the Effects of Pasireotide LAR Administration on Lymphocele Prevention after Axillary Node Dissection for Breast Cancer: Results of a Randomized Non-Comparative Phase 2 Study

International audienceObjectiveThe aim of this study was to assess the efficacy (response rate centered on 80%) of a somatostatin analog with high affinity for 4 somatostatin receptors in reducing the postoperative incidence of symptomatic lymphocele formation following total mastectomy with axillary lymph node dissection.SettingThis prospective, double-blind, randomised, placebo-controlled, phase 2 trial was conducted in two secondary care centres.ParticipantsAll female patients for whom mastectomy and axillary lymph node dissection were indicated were eligible for the study, including patients who had received neo-adjuvant chemotherapy. Main exclusion criteria were related to diabetes, cardiac insufficiency, disorder of cardiac conduction or hepatic failure.InterventionsPatients were randomised to receive one injection of either prolonged-release pasireotide 60 mg or placebo (physiological serum), which were administered intramuscularly 7 to 10 days before the scheduled surgery. The study was conducted in a double-blind manner.Primary and Secondary Outcome MeasuresThe primary outcome measure was the percentage of patients who did not develop post-operative axillary symptomatic lymphoceles during the 2 postoperative months. Secondary endpoints were the total quantity of lymph drained, duration and daily volume of drainage and aspirated volumes of lymph.ResultsNinety-one patients were randomised. Ninety patients were evaluable: 42 patients received pasireotide, and 48 patients received placebo. The mean estimated response rate were 62.4% (95% Credibility Interval [CrI]: 48.6%-75.3%) in the treatment group and 50.2% (95% CrI: 37.6%-62.8%) in the placebo group. Overall safety was comparable across groups, and one serious adverse event occurred. In the treatment group, one patient with known insulin-depe*ndent diabetes required hospitalization for hyperglycaemia.ConclusionsWith this phase 2 preliminary study, even if our results indicate a trend towards a reduction in symptomatic lymphocele, pre-operative injection of pasireotide failed to achieve a response rate centered on 80%. Pharmacokinetics analysis suggests that effect of pasireotide could be optimised

Quilting sutures reduces seroma in mastectomy

Background Drainage duration and seroma formation occurring after mastectomy with or without axillary surgery lengthens hospitalization and delays adjuvant treatment. The aim of the study was to evaluate the effect of quilting in the prevention of seroma after mastectomy for breast cancer. Patients and Methods Eighty-two breast cancer patients about to undergo mastectomy with or without axillary surgery lymphadenectomy were enrolled in the study. We conducted an observational comparison between 41 patients in whom quilting with closed suction drainage was used and 41 patients in whom drainage only was used. Results The mean drained volume was significantly lower in the quilting group compared with the control group on days 1 and 2 (day 1: 107.1 mL vs. 156.5 mL; P =.02; day 2: 108.4 mL vs. 162.8 mL; P =.01). The mean drainage period was shorter in the quilting group (4.6 vs. 5.3 days; P =.046). There were fewer needle aspirations for seroma in the padding group (n = 14, 34.1% vs. n = 24, 58.5%; P =.03). Conclusion The use of padding after mastectomy seems to reduce seroma formation, volume drained, and length of drainage tim

Post-operative courses.

<p>Post-operative courses.</p

Primary outcome results.

<p>Primary outcome results.</p

Trial design.

<p>Trial design.</p

Patient and surgical characteristics.

<p>Patient and surgical characteristics.</p

Daily drainage quantities.

<p>Daily drainage quantities.</p