Beschreibung: Introduction Perioperative chemotherapy is the gold standard treatment of the resectable gastro-oesophageal adenocarcinoma. However, 70% of patients cannot receive the complete sequence because of a postoperative complication or a decrease in functional and nutritional reserves. Recently, a new concept appeared in digestive surgery: prehabilitation. This interventional process consists of patient preparation, between surgical consultation and surgery, and is based on 3 components: (1) physical management, (2) nutritional care and (3) psychological care. Prehabilitation should decrease postoperative complications and improve nutritional and physical status during the preoperative and postoperative periods. Therefore, it is becoming essential to evaluate the effect of prehabilitation, compared to conventional care, on the percentage of patients reaching the complete oncological treatment. Methods and analysis The PREHAB trial aimed to evaluate the efficacy of prehabilitation compared to conventional care, in patients with gastro-oesophageal cancer with perioperative chemotherapy. This trial is a prospective, randomised, controlled, open-blind and interventional study in 4 centres. Patients (n=60 per group) will be randomly assigned for management with either prehabilitation or conventional care. The primary outcome is the percentage of patients reaching the complete oncological treatment decided in a multidisciplinary tumour board. The secondary outcomes are the postoperative morbidity, disease-free survival, overall survival, feasibility of the protocol, length of stay, variation of the functional reserve after the preoperative chemotherapy (defined by the VO 2peak , ventilatory threshold and 6-min walk test), preoperative and postoperative nutritional status, preoperative anxiety, quality of life, 30-day and 90-day mortality and cumulative dose of cytotoxic treatment received. Ethics and dissemination The study was approved by an independent medical ethics committee (IRB00008526, CPP Sud-Est VI, Clermont-Ferrand, France) and by the competent French authority (ANSM, Saint Denis, France) and registered on Clinicaltrial.gov . The results will be disseminated in a peer-reviewed journal. Trial registration number NCT02780921.

Beschreibung: Introduction Elderly patients constitute an increasingly large proportion of the high-risk surgical group. In adult patients, several specific intraoperative approaches such as cardiac output-guided haemodynamic therapy, depth of anaesthesia monitoring (DAM) or lung-protective ventilation (LPV) are designed to reduce postoperative mortality and surgical complications. However, none of these approaches has been specifically performed in the elderly, and no evaluation of a multimodal optimisation strategy for general anaesthesia has been achieved in this population. Aims The objective of this study is to assess, in high-risk patients aged 75 years and over undergoing high-risk surgery, the effectiveness of combined optimisation of anaesthesia involving goal-directed haemodynamic therapy (GDHT), LPV and electroencephalographic DAM on postoperative morbidity and mortality. The primary outcome of the study is a composite criterion associating major postoperative complications and mortality occurring within the 30 first postoperative days. The secondary outcomes are 1-year postoperative autonomy and mortality. Methods and analysis This prospective, randomised, controlled, multicentre trial using a stepped wedge cluster design will be conducted in 27 French university centres. Patients aged 75 years and over, undergoing femoral head fractures and major intraperitoneal or vascular elective surgeries will be included after informed consent. They will benefit from usual care in the ‘control group’ and from a combined optimisation of general anaesthesia involving GDHT, LPV and DAM in the ‘optimisation group’. The cluster’s crossover will be unidirectional, from control to optimisation, and randomised. Data will be recorded at inclusion, the day of surgery, 7 days, 30 days and 1year postoperatively and collected into a hosted electronic case report form. The primary outcome of the study is a composite criterion associating major postoperative complications and mortality occurring within the 30 first postoperative days. The secondary outcomes are 1- year postoperative autonomy and mortality. Ethics and dissemination This protocol was approved by the ethics committee Sud-Est 1 and the French regulatory agency. The finding of the trial will be disseminated through peer-reviewed journals and conferences Trial registration number NCT02668250; Pre-results.