[Short version of recommendations for enhanced recovery program (ERP) for cystectomy: Technical measures]. / Version courte des recommandations de la récupération ameliorée après chirurgie (RAAC) pour la cystectomie : mesures techniques.

INTRODUCTION: The enhanced recovery program (ERP) is a management mode whose objective is to reduce the risk of complications and allow the patient to recover more quickly all its functional capacities and to reintegrate at most quickly and safely in his usual environment. This intentionally synthetic document aims to disseminate in the urological community the main points of the ERP recommendations for cystectomy. This work, coordinated by AFU, involves several other partners. The full document is available on the "Urofrance" website. Another article will follow on organizational measures. METHOD: The development of the recommendations is based on the method "formalized consensus of experts" proposed by the HAS. The report is based on a systematic review of the literature (January 2006-May 2017), two rounds of iterative quotations and a national proofreading. Levels of proof of conclusions and gradation of recommendations are based on the HAS grid. RESULTS: The bibliographic strategy made it possible to retain 298 articles. Only the recommendations that obtained a strong agreement after the two rounds of iterative listing were retained. The recommendations presented here are in chronological form (before, during, after hospitalization). Twenty-six key points on the technical and organizational measures of ERP have been identified. CONCLUSION: The result of the literature review, supplemented by expert opinion, suggests a significant clinical interest in the application and dissemination of ERP for cystectomy, despite the limited data available for this indication.

[Mastectomy in ambulatory hospitalization or 24hours: Feasibility, satisfaction and preferences of the patients]. / Mastectomie en hospitalisation ambulatoire ou de 24heures : faisabilité, satisfaction et préférences des patientes.

The aim of this study is to analyze the feasibility of ambulatory hospitalization or 24hours hospitalization for breast cancer treatment by mastectomy, as well as the satisfaction and the preferences of patients with regard to these ways of hospitalization. METHODS: This observational retrospective study listed the patients operated for breast cancer who had required a mastectomy at the institute Paoli-Calmettes between the 1st of January 2013 and June 30th, 2015. A questionnaire of satisfaction was proposed to the patients regarding their mode of hospitalization. RESULTS: One hundred and thirteen patients were included among which 29 were in the ambulatory group and 84 in the 24hours hospitalization group. The complications were represented by the rate of hematomas (3.5 %), which required a surgical resumption for two of the patients in the 24hours hospitalization group and for one patient in the ambulatory group (P=0.75). Patient's satisfaction rate was globally high: 72.7 % regardless of the mode of hospitalization (P=0.064). CONCLUSION: The realization of mastectomy in ambulatory hospitalization seems feasible when the organization in pre- and postoperative is anticipated with a high degree of satisfaction of the patients. The psychological impact of this radical surgery seems to be a factor to be taken into account and requires a meticulous selection of the patients.

Severity of Acute Respiratory Distress Syndrome in haematology patients: long-term impact and early predictive factors.

Severe forms of acute respiratory distress syndrome in patients with haematological diseases expose clinicians to specific medical and ethical considerations. We prospectively followed 143 patients with haematological malignancies, and whose lungs were mechanically ventilated for more than 24 h, over a 5-y period. We sought to identify prognostic factors of long-term outcome, and in particular to evaluate the impact of the severity of acute respiratory distress syndrome in these patients. A secondary objective was to identify the early (first 48 h from ICU admission) predictive factors for acute respiratory distress syndrome severity. An evolutive haematological disease (HR 1.71; 95% CI 1.13-2.58), moderate to severe acute respiratory distress syndrome (HR 1.81; 95% CI 1.13-2.69) and need for renal replacement therapy (HR 2.24; 95% CI 1.52-3.31) were associated with long-term mortality. Resolution of neutropaenia during ICU stay (HR 0.63; 95% CI 0.42-0.94) and early microbiological documentation (HR 0.62; 95% CI 0.42-0.91) were associated with survival. The extent of pulmonary infiltration observed on the first chest X-ray and the diagnosis of invasive fungal infection were the most relevant early predictive factors of the severity of acute respiratory distress syndrome.

Early diastolic dysfunction is associated with intensive care unit mortality in cancer patients presenting with septic shock.

BACKGROUND: Cancer patients present a high risk of sepsis and are exposed to cardiotoxic drugs during chemotherapy. Myocardial dysfunction is common during septic shock and can be evaluated at bedside using echocardiography. The aim of this study was to identify early cardiac dysfunctions associated with intensive care unit (ICU) mortality in cancer patients presenting with septic shock. METHODS: Seventy-two cancer patients admitted to the ICU underwent echocardiography within 48 h of developing septic shock. History of malignancies, anticancer treatments, and clinical characteristics were prospectively collected. RESULTS: ICU mortality was 48%. Diastolic dysfunction (e' ≤8 cm s(-1)) was an independent echocardiographic parameter associated with ICU mortality {odds ratio (OR) 7.7 [95% confidence interval (CI), 2.58-23.38]; P<0.001}. Overall, three factors were independently associated with ICU mortality: sepsis-related organ failure assessment score at admission [OR 1.35 ( 95% CI, 1.05-1.74); P=0.017], occurrence of diastolic dysfunction [OR 16.6 (95% CI, 3.28-84.6); P=0.001], and need for conventional mechanical ventilation [OR 16.6 (95% CI, 3.6-77.15); P<0.001]. Diastolic dysfunction was not associated with exposure to cardiotoxic drugs. CONCLUSIONS: Early diastolic dysfunction is a strong and independent predictor of mortality in cancer patients presenting with septic shock. It is not associated with exposure to cardiotoxic drugs. Further studies incorporating monitoring of diastolic function and therapeutic interventions improving cardiac relaxation need to be evaluated in cancer patients presenting with septic shock.

Critically ill cancer patients in the intensive care unit: short-term outcome and 1-year mortality.

BACKGROUND: The short-term survival of critically ill patients with cancer has improved over time. Studies providing long-term outcome for these patients are scarce. METHODS: We prospectively analyzed outcomes and rates of successful discharge of 111 consecutive critically ill cancer patients admitted to intensive care unit (ICU) in 2008 and identified factors influencing these results. RESULTS: ICU mortality was 32% and hospital mortality was 41%. None of the characteristics of the malignancy nor age or neutropenia were significantly different between survivors and others. Two variables were independently associated with ICU mortality: high Logistic Organ Dysfunction score on day 7 and a diagnosis of viral infection and/or reactivation. The 1-year mortality rate for ICU survivors was 58% and was significantly lower in patients with a diagnosis of acute leukemia or multiple myeloma. CONCLUSION: Organ failure scores on day 7 can predict outcome for cancer patients in the ICU. Viral infection and reactivation appear to worsen the prognosis. One-year mortality rate is high and depends on the malignancy.

[Assessment of the French surgical checklist: the experience of 17 French cancer centres]. / Évaluation et applicabilité de la check-list HAS au quotidien: expérience des centres de lutte contre le cancer.

INTRODUCTION: The use of WHO checklist has been associated to a decrease of complication incidence and mortality. This control is mandatory since January the 1st 2010. Evaluation of the quality of documentation is important and includes filling rate, which is a reflexion of participant adhesion and analysis of the circumstances where the team answers "no" during the control. METHODS: This study concerned 17 among 20 French cancer centres. Percentage of documented checklist, exhaustivity of the answers in each checklist and "no" answers have been compared during two periods: January 2010 and October 2010. RESULTS: Rate of filled document is satisfactory and stable during the two periods (95.5% versus 95.8%). Exhaustivity was slightly better during the second period (64 and 68%, P=0,039). Nevertheless, variability between centres was large; one centre improved and four centres worsened their scores. Rate of "no" answers was low and increased during the second period (1.5% in January 1.9% in October P<0.001). They mainly concerned antibiotic administration and at a lesser degree bleeding risk, the name of the procedure, equipment problem to be addressed and postoperative management. DISCUSSION: There is a large discrepancy between centres and for a given centre in reporting quality. Significant progress should be expected using target improvement. This approach implies multiple critical analysis of checklist content in each hospital and in multicentre enquiries.

HLA-DR and B7-2 (CD86) monocyte expressions after major cancer surgery: profile in sepsis.

AIM: HLA-DR monocyte expression may be affected by major surgery. A potential mechanism for monocyte activation is the engagement of costimulatory receptors (B7-2 or CD-86). The aim of the present study was to determine the possible role of monocyte HLA-DR and B7-2 molecules in the occurrence of postoperative sepsis after major cancer surgery. METHODS: This was an observational study in 25 consecutive patients undergoing major elective surgery. Flow cytometry measures were used to determine the expression of HLA-DR and its costimulatory receptors before (day 0) and after surgery (day 1 and day 2). RESULTS: After surgery, the rate of monocytes expressing HLA-DR decreased significantly in all the patients. As compared with day 0, the rate of monocytes expressing B7-2 decreased in all the patients (P<0.03). In the septic group, it remained significantly decreased postoperatively. In the non-septic group, it reached baseline levels at day 2. CONCLUSION: Results suggest a key role for costimulatory molecules in modulating inflammatory response in the context of subsequent postoperative sepsis after major cancer surgery. These molecules may be involved, in association with HLA-DR, in postoperative monocyte dysfunction.

Reduced interleukin-12 release from stimulated monocytes in patients with sepsis after major cancer surgery.

BACKGROUND: Major cancer surgery is a high-risk situation for sepsis in the post-operative period. The aim of this study was to assess the relation between the monocyte production of IL-12 and the development of post-operative sepsis in patients undergoing major cancer surgery. METHODS: In 19 patients undergoing major cancer surgery, the production of cytokines by basal and lipolysaccharide (LPS)-stimulated monocytes was measured before and after (from day 1 to day 3 and day 7) surgery. Seven of them developed a post-operative sepsis. Ten healthy volunteers were used as controls for the assessment of pre-operative values. RESULTS: Before surgery, the production of interleukin (IL)-12 p40 by LPS-stimulated monocytes was similar in the patients and the healthy volunteers. The production of IL-12 p40 by unstimulated monocytes was higher in the patients than in the healthy volunteers. IL-12 production did not differ between the septic and the non-septic patients. After surgery, the production of IL-12 p40 was dramatically reduced in the LPS-stimulated monocytes of the septic patients from day 1 to day 3, as compared with that of the non-septic patients. Before surgery, the production of IL-6, IL-10, and IL-1 receptor antagonist (IL-1ra) in the patients was significantly higher than that of the healthy volunteers for both stimulated and unstimulated monocytes. After surgery, the production of these cytokines by both stimulated and unstimulated monocytes of the septic patients was similar to that of the non-septic patients. Intragroup analysis showed significant changes for IL-6, IL-10, and IL-1ra under all conditions, with the exception of changes in unstimulated monocytes of septic patients that were not significant for IL-10 release. CONCLUSION: After surgery, the septic patients showed drastic failure to up-regulate monocyte LPS-stimulated production of IL-12 p40.

Robot-assisted laparoscopy in gynecologic oncology.

OBJECTIVES: The aim of this prospective study was to evaluate the feasibility and the outcome of gynaecological cancer surgery with the Da Vinci S surgical system (Intuitive Surgical). METHODS: From February 2007 to September 2007, 28 patients underwent 32 gynaecological procedures in a single centre. Surgical procedures consisted of total hysterectomy, bilateral oophorectomy, and pelvic and/or lombo-aortic lymphadenectomy. In all cases, surgery was performed using both laparoscopic and robot-assisted laparoscopic techniques. In this heterogeneous series, a subgroup of 12 patients treated for advanced cervical cancer was compared with a retrospective series of 20 patients who underwent the same surgical procedure by laparotomy. RESULTS: Mean age of the entire population was 52.5 years (range 25-72 years) and mean body mass index (BMI) was 25 kg/m(2) (range 18-40 kg/m(2)). Indications for surgery were cervical cancer in 21 cases, endometrial cancer in 7 cases, ovarian cancer in 1 case and cervical dysplasia in 3 cases. Median operating time was 180 min (mean 175.25 min, range 80-360 min) and median estimated blood loss was 110 cc (range 0-400 cc); no transfusions were necessary. No perioperative complications were observed and median time of hospitalisation was 3 days (mean 3.9 days, range 2-8 days). In the subgroup of 12 advanced cervical cancer a significant difference was observed in terms of hospital stay compared with laparotomy; no difference was observed concerning operative time. Fewer complications were observed with laparotomy (33% versus 25%) but more serious complications than with robot-assisted laparoscopy. CONCLUSION: As suggested in the literature, the use of robot-assisted laparoscopy leads to less intraoperative blood loss, less post operative pain and shorter hospital stays compared with those treated by more traditional surgical approaches. Despite the need for more extensive studies, robot-assisted surgery seems to represent a similar technological evolution as the laparoscopic approach 50 years ago.

[Major hepatectomy for metastasis of colorectal cancer improves survival in the elderly]. / Hépatectomie majeure pour métastases de cancers colorectaux chez le sujet âgé.

OBJECTIVE: Assessing impact of major liver resection (LR) for hepatic metastasis of colorectal cancer (HMCC) on post operative courses and long term survival in the elderly. PATIENTS AND METHOD: Thirty-three consecutive patients aged over 70 years-old were treated in our institution for up to 3 resectable metachronous HMCC. Fifteen patients had major LR (9 right hepatectomy, 3 extended right hepatectomy, 3 left hepatectomy) without pre or postoperative chemotherapy (group 1) and 18 patients were exclusively treated by chemotherapy (group 2) because of high ASA score (ASA 3) or patients refusal. RESULTS: No patients died of another cause that colorectal cancer disease during observation time. All patients of group 2 died during observation time. Post operative mortality and morbidity of group 1 were respectively 0% and 33%. Survival at 1 and 2 years of group 1-2 were respectively 73-50% (P=0,04) and 47-15% (P=0,05). Median survival of group 1 and 2 were respectively 22 and 12 months (P=0,03). CONCLUSIONS: Major LR for HMCC could be proposed regardless the age. High ASA score, multiple (more than 4) metastasis location, evolutive disease could justify an exclusive medical approach.

Predictive perioperative factors for developing severe sepsis after major surgery.

BACKGROUND: Early identification of high-risk patients undergoing major surgery can result in an aggressive management affecting the outcome. METHODS: We designed a prospective cohort study of 93 adult patients undergoing major oncological surgery to identify the predictive risk factors for developing postoperative severe sepsis. RESULTS: Nineteen of 93 patients developed a severe sepsis after surgery; seven of the septic patients died in intensive care unit. Multivariate analysis discriminated preoperative and postoperative (first and second day after surgery) predictive risk factors. The postoperative severe sepsis was independently associated with preoperative factors like male gender (OR 4.7, 95% CI between 1.5 and 15.5, P<0.01) and Charlson co-morbidity index (OR 1.3, 95% CI between 1.07 and 1.6, P<0.01). After the surgery, the presence of systemic inflammatory response syndrome (OR 4.0, 95% CI between 1.02 and 15.7, P<0.05) and a logistic organ dysfunction score on day 2 (OR 3.3, 95% CI between 1.9 and 5.7, P<0.001) were found as independent predictive factors. CONCLUSION: We have shown that some of the markers that can be easily collected in the preoperative or postoperative visits can be used to screen the patients at high risk for developing severe sepsis after major surgery.

Procalcitonin, interleukin 6 and systemic inflammatory response syndrome (SIRS): early markers of postoperative sepsis after major surgery.

BACKGROUND: Patients who undergo major surgery for cancer are at high risk of postoperative sepsis. Early markers of septic complications would be useful for diagnosis and therapeutic management in patients with postoperative sepsis. The aim of this study was to investigate the association between early (first postoperative day) changes in interleukin 6 (IL-6), procalcitonin (PCT) and C-reactive protein (CRP) serum concentrations and the occurrence of subsequent septic complications after major surgery. METHODS: Serial blood samples were collected from 50 consecutive patients for determination of IL-6, PCT and CRP serum levels. Blood samples were obtained on the morning of surgery and on the morning of the first postoperative day. RESULTS: Sixteen patients developed septic complications during the first five postoperative days (group 1), and 34 patients developed no septic complications (group 2). On day 1, PCT and IL-6 levels were significantly higher in group 1 (P-values of 0.003 and 0.006, respectively) but CRP levels were similar. An IL-6 cut-off point set at 310 pg ml(-1) yielded a sensitivity of 90% and a specificity of 58% to differentiate group 1 patients from group 2 patients. When associated with the occurrence of SIRS on day 1 these values reached 100% and 79%, respectively. A PCT cut-off point set at 1.1 ng ml(-1) yielded a sensitivity of 81% and a specificity of 72%. When associated with the occurrence of SIRS on day 1, these values reached 100% and 86%, respectively. CONCLUSIONS: PCT and IL-6 appear to be early markers of subsequent postoperative sepsis in patients undergoing major surgery for cancer. These findings could allow identification of postoperative septic complications.

A reappraisal of preoperative chemoradiation for localized pancreatic head ductal adenocarcinoma in a 5-year single-institution experience.

Resection of localized pancreatic head ductal adenocarcinoma (LPHDA) has a limited impact on survival. Mechanisms of improvement provided by preoperative chemoradiation therapy (CRT) remain under debate. This study analyzes the outcome of patients treated for LPHDA to delineate the benefits of CRT. Among 87 patients with LPHDA, 17 had a pancreaticoduodenectomy alone (group I). Thirty-nine with initially resectable cancers received CRT with 5-fluorouracil-based chemotherapy (group II). Thirty-one with initially unresectable cancers were similarly treated by CRT (group III). Patients in groups II and III were restaged after completion of CRT. In patients with resectable disease, resection was planned. Patients in groups I and II were statistically comparable in terms of age, sex, and pretherapeutic stage. Median survival and 2-year overall survival in group I were 13.7 months and 31%, respectively. In group II, 23 patients (59%) had a pancreaticoduodenectomy (group IIa) and 16 patients (41%) did not have resection (group IIb). Median survival and 2-year overall survival were as follows: group IIa, 26.6 months and 51%; and group IIb, 6.1 months and 0%, respectively. In group IIa, pathologic examination revealed eight major responses (35%) including two sterilized specimens, and none of the patients had locoregional recurrence. In group III, none of the patients had resection, and median survival was 8 months with one 2-year survivor. Patient selection appears to play a major role with regard to results achieved with preoperative CRT followed by pancreaticoduodenectomy. However, a high histologic response rate and excellent local control can also be achieved.

Early postoperative compensatory anti-inflammatory response syndrome is associated with septic complications after major surgical trauma in patients with cancer.

BACKGROUND: Patients who undergo major surgery for cancer are at high risk of postoperative infection. Postoperative immunosuppression may be due to dysregulation of cytokine production. The aim of this study was to investigate the association between changes in serum proinflammatory and anti-inflammatory cytokine concentrations and postoperative septic complications after major surgery. METHODS: Serial blood samples were collected from 30 consecutive patients for determination of serum cytokine levels. Healthy volunteers were used as the control group. RESULTS: Eleven patients developed no complications (group 1), 14 developed sepsis or severe sepsis (group 2), and five developed septic shock (group 3). On day 1 the patients in groups 2 and 3 had significantly higher levels of interleukin (IL) 6 than those in group 1. IL-6 levels remained high until day 5. Tumour necrosis factor (TNF), IL-1, interferon (IFN) gamma and IL-12 levels were not affected by surgical trauma or by the occurrence of septic complications. After operation the circulating IL-1 receptor antagonist (IL-1ra) concentration was increased in all groups, but patients in group 3 had significantly higher levels of IL-1ra than those in group 1. IL-1ra levels correlated with IL-6 levels. The pattern of IL-10 levels was similar to that of IL-1ra levels. CONCLUSION: Serum concentrations of proinflammatory cytokines (TNF, IL-1, IFN-gamma and IL-12) were not affected by operation or the occurrence of septic complications. The postoperative increase in IL-6 concentration was associated with septic morbidity, while raised IL-1ra concentration was associated with postoperative septic shock.

[A scale of perioperative satisfaction for anesthesia. I--Construction and validation]. / Echelle de vécu périopératoire de l'anesthésie. I--construction et validation.

OBJECTIVE: To develop and to validate a scale assessing perioperative patient's satisfaction with anaesthesia (Evan). STUDY DESIGN: Descriptive and evaluative study. PATIENTS: The study included 742 adults undergoing a surgical or a diagnostic procedure under general anaesthesia. Emergency, ambulatory and obstetrical cases were excluded. METHODS: A multidisciplinary working party produced 85 questions focusing on various pertinent areas describing satisfaction. After a validation, 25 out of them were selected for the questionnaire. The latter was completed within the 24 hours following anaesthesia by 742 inpatients. RESULTS: Item analysis showed a homogeneous distribution of the answers to each item. Main component analysis allowed to explain 53% of total variance. Six dimensions were isolated by the exploratory analysis: anxiety, embarrassment, fear, pain-discomfort, information and physical needs. Scoring method followed a simple additive model: for each dimension, the scale scored 0-100. The global score represented the sum of the six dimensions also scored 0-100. Acceptability of Evan questionnaire was satisfactory, with a spontaneous non response rate of less than 1% and a completion duration at 11 +/- 8 min. CONCLUSION: A self-completed questionnaire on patient's satisfaction with anaesthetic period was validated, allowing a global and multidimensional assessment of patient's satisfaction.

[A scale of perioperative satisfaction for anesthesia. II--Preliminary results]. / Echelle de vécu périopératoire de l'anesthésie. II--Résultats préliminaires.

PURPOSE: To assess the patient's experience of anaesthesia in the early postoperative period, with a self-completed questionnaire (Evan). STUDY DESIGN: Descriptive and evaluative study. PATIENTS: The study included 742 adults undergoing an elective surgical or non surgical procedure under anaesthesia. METHODS: An Evan questionnaire with 25 questions was completed 24 hours after anaesthesia by the patient. The questionnaire explored six areas, each one being marked out from 0 to 100, as the visual analogue scale. The marks were compared with consideration of age, gender, ASA physical class, type of anaesthesia, anaesthesia duration and type of surgery. RESULTS: The mean global mark was 76 +/- 9 (min-max: 34-99). Marks were lower in the youngest patients, in females, in ASA 1 patients, in longest surgical procedures, especially with regard to areas belonging to "apprehension", "pain-discomfort" and "physical needs". The lowest mark was given for the "information" provided during the pre-anaesthetic evaluation. Differences in marks occurred also between surgical specialities. CONCLUSION: The Evan questionnaire is a valuable tool for assessing the patient's opinion on the perioperative period. Further studies are required to extend its use to other fields, as ambulatory surgery.

Production of ex vivo expanded hematopoietic cells and progenitors in a closed bioreactor, starting with a small volume marrow collection: A feasibility study in patients with poor-risk breast cancer and receiving high-doses of cyclophosphamide.

We report a clinical pilot study conducted in 6 women with poor-prognosis breast cancer. The goal was to evaluate the feasibility and safety of producing hematopoietic progenitors and cells from a small marrow sample, for clinical use after high-dose cyclophosphamide. A small volume marrow collection was obtained, using local anesthesia and conscious sedation, before the first of two chemotherapy cycles. Cells were cryopreserved, and later thawed to inoculate two Aastrom Biosciences Inc Replicell bioreactors, on time to reinfuse ex vivo expanded cells after the second chemotherapy cycle. Patients recovered neutrophils and platelets at similar times after the first and second chemotherapy cycles, and showed comparable clinical events. This pilot study prepares future randomized trials, designed to evaluate clinical benefits associated with the use of ex vivo expanded cells in the setting of multicycle high-dose chemotherapy.

Optimization of peripheral blood stem cell collection by leukopheresis. Interaction between economic and clinical assessment of an innovation.

Using the example of substitution of peripheral blood stem cell (PBSC) collection to bone marrow harvest for autologous transplantation in cancer patients, our study attempts to illustrate how economic assessment, starting at an early stage of medical innovation, can influence the development and diffusion process of a new technological procedure whose optimal design has not yet been established. Two cost minimization studies comparing costs for obtaining a clinically reinfusable graft using bone marrow harvest or alternatively various protocols of PBSC collection contributed to a change in the French clinical standard for this procedure.