Évaluation préliminaire de l'impact d'un stage pilote d'initiation à la gestuelle chirurgicale sur l'acquisition des habiletés techniques de base par les internes de chirurgie de premier semestre

Contexte : L'apprentissage de l'habileté technique chirurgicale (HTC) dans le système français de formation en chirurgie repose essentiellement sur l'immersion en situation réelle et le compagnonnage. De nouvelles contraintes pèsent sur l'exercice de la chirurgie dans les centres hospitaliers universitaires et pourraient réduire l'efficience de ce mode unique de transmission de l'HTC. Objectif : Évaluer l'impact sur l'acquisition de gestes chirurgicaux élémentaires (suture, ligature) d'un stage d'initiation à la gestuelle chirurgicale (SIGC) basé sur l'apprentissage et l'entraînement sur modèle inanimé hors bloc opératoire en complément du mode habituel d'apprentissage par immersion compagnonnage. Méthodes : Nous avons comparé lors d'un exercice standardisé de suture et ligature proposé 3 mois après le début du premier stage hospitalier, les performances (scores et durée) d'un groupe d'internes premier semestre exposé au SIGC, à celles d'un groupe d'internes premier semestre non exposés. Résultats : La moyenne du score de performance obtenu, était de 23,9 (15–28) pour le groupe exposé contre 17,1 (2–24) pour le groupe non exposé (p=0{,}036). Le test de connaissance du matériel était aussi en faveur du groupe exposé. Le temps moyen de suture ne montrait qu'une tendance en faveur du groupe exposé. Conclusion : Nos résultats suggèrent un impact positif et mesurable d'un stage de technique préliminaire en début d'internat de chirurgie sur la rapidité d'acquisition de gestes de base de chirurgie. Ce type d'enseignement basé sur la simulation pourrait être un complément essentiel au principe d'immersion/compagnonnage pour la transmission de l'HTC

Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node

Abstract Background Three randomized trials have concluded at non inferiority of omission of complementary axillary lymph node dissection (cALND) for patients with involved sentinel node (SN). However, we can outline strong limitations of these trials to validate this attitude with a high scientific level. We designed the SERC randomized trial (ClinicalTrials.gov, number NCT01717131) to compare outcomes in patients with SN involvement treated with ALND or no further axillary treatment. The aim of this study was to analyze results of the first 1000 patients included. Methods SERC trial is a multicenter non-inferiority phase 3 trial. Multivariate logistic regression analysis was used to identify independent factors associated with adjuvant chemotherapy administration and non-sentinel node (NSN) involvement. Results Of the 963 patients included in the analysis set, 478 were randomized to receive cALND and 485 SLNB alone. All patient demographics and tumor characteristics were balanced between the two arms. SN ITC was present in 6.3% patients (57/903), micro metastases in 33.0% (298), macro metastases in 60.7% (548) and 289 (34.2%) were non eligible to Z0011 trial criteria. Whole breast or chest wall irradiation was delivered in 95.9% (896/934) of patients, adjuvant chemotherapy in 69.5% (644/926), endocrine therapy in 89.6% (673/751) and the proportions were similar in the two arms. The overall rate of positive NSN was 19% (84/442) for patients with cALND. Crude rates of positive NSN according to SN status were 4.5% for ITC (1/22), 9.5% for micro metastases (13/137), 23.9% for macro metastases (61/255) and were respectively 29.36% (64/218), 9.33% (7/75) and 7.94% (10/126) when chemotherapy was administered after cALND, before cALND and for patients without chemotherapy. Conclusion The main objective of SERC trial is to demonstrate non inferiority of cALND omission. A strong interaction between timing of cALND and chemotherapy with positive NSN rate was observed. Trial registration This study is registered with ClinicalTrials.gov, number NCT01717131 October 19, 2012

Sentinel node involvement with or without completion axillary lymph node dissection: treatment and pathologic results of randomized SERC trial

International audienceBased on results of clinical trials, completion ALND (cALND) is frequently not performed for patients with breast conservation therapy and one or two involved sentinel nodes (SN) by micro- or macro-metastases. However, there were limitations despite a conclusion of non-inferiority for cALND omission. No trial had included patients with SN macro-metastases and total mastectomy or with >2 SN macro-metastases. The aim of the study was too analyze treatment delivered and pathologic results of patients included in SERC trial. SERC trial is a multicenter randomized non-inferiority phase-3 trial comparing no cALND with cALND in cT0-1-2, cN0 patients with SN ITC (isolated tumor cells) or micro-metastases or macro-metastases, mastectomy or breast conservative surgery. We randomized 1855 patients, 929 to receive cALND and 926 SLNB alone. No significant differences in patient’s and tumor characteristics, type of surgery, and adjuvant chemotherapy (AC) were observed between the two arms. Rates of involved SN nodes by ITC, micro-metastases, and macro-metastases were 5.91%, 28.12%, and 65.97%, respectively, without significant difference between two arms for all criteria. In multivariate analysis, two factors were associated with higher positive non-SN rate: no AC versus AC administered after ALND (OR = 3.32, p 2 involved SN versus ≤2 (OR = 3.45, p = 0.0258). Crude rates of positive NSN were 17.62% (74/420) and 26.45% (73/276) for patient’s eligible and non-eligible to ACOSOG-Z0011 trial. No significant differences in patient’s and tumor characteristics and treatment delivered were observed between the two arms. Higher positive-NSN rate was observed for patients with AC performed after ALND (17.65% for SN micro-metastases, 35.22% for SN macro-metastases) in comparison with AC administered before ALND