[Implementation of a territorial hospital pharmacy (PUI) ensuring a robotized nominative dispensation of treatments for two external sites: A dependent old people's home (EHPAD) and a follow-up care institution (SSR)]. / Carnet de bord pour la mise en place d'une PUI territoriale assurant une dispensation nominative robotisée des traitements pour deux sites extérieurs : Un EHPAD et un SSR.

The territorial hospital pharmacy (PUI) of the West of Paris, dispenses treatments for a follow-up care instituion (SSR) and a dependent old people's home (EHPAD) via a hospital pharmacy equipped with an automatic machine producing dry oral forms packaged in labeled pillboxes. This project was completed with the support of the Regional Health Agency (ARS) and aims to secure the medication circuit. The methodology for qualifying the computer system and production, the implementation of the medication circuit and the inter-site logistical organization are presented. The prescription software was interfaced with the management software, which is itself interfaced with the robot's, and with the automatic machine's software. Tests and developments allowed to convert dispensing units into prescription units over a period of time. Also, the drugs consumed by these two institutions allowed to establish the therapeutic booklet and drug provision as well as anticipating the automaton filling. Medical devices, solutions and narcotics are exclusively managed as supplies with a specific circuit. Treatments are dispensed weekly (pillboxes and off-robot). For the SSR, an additional daily production concerns the entries of new patients and the modifications of treatment. Automation saves time and security, but human intervention is involved on a daily basis. The institutions have adopted the new organization over about 6 months and the production activity is now smoothed out. In the next few weeks, two other EHPADs with 100 patients will be integrated into the PUI territorial. One of the main challenges is to integrate them into our pre-existing organization, while maintaining their habits.

[Methodology to develop a virtual reality training for good practices in the preparation of anti-cancer drugs]. / Méthodologie pour développer une formation aux bonnes pratiques de préparation des anticancéreux en réalité virtuelle à 360°.

OBJECTIVE: Describe the process for designing and creating SimUPAC 360°, a virtual reality training in anti-cancer drug production units. METHODS: A multi-centre (a University Hospital, a General Hospital and a Cancer Control Centre), inter-professional (pharmacists, hospital pharmacy technicians and health executives) working group has been set up. It was based on videoconferencing and online document sharing. The work was divided into six phases: choice of target audience and training objectives, definition of the business model, development of the scenario, shooting and editing, creation of the training tool and finally tests, adjustments and validation of the tool. RESULTS: After brainstorming, 77 errors were proposed. Three areas have been defined: covering area, storage and production area, and isolator. They contained 15 errors among the 77 proposed and 20 points of interest. The shooting was carried out over 2 days, in 2 hospitals. Assembly was carried out by a service provider specialist in real virtuality. Before to go online, the tool was tested and validated by experts. DISCUSSION: The establishment of a multi-centric and interdisciplinary working group, the choice of target audience, pedagogical objectives and business model ensure the economic viability and scientific and technical robustness of the tool. The scenario development requires to define: activity areas and then, number, difficulty and typology of errors. CONCLUSION: Creation of a virtual reality training requires a consistent and structured methodology. This methodology will make it possible to develop other training scenarios.

Splenic infarction associated with transient anti-prothrombin antibodies is a rare manifestation of acute Mycoplasma pneumoniae infection.

We report the first paediatric case of splenic infarction following acute Mycoplasma pneumoniae infection with induction of anti-prothrombin (aPT) antibodies. A 12-year-old boy was admitted to the paediatric emergency department for a left pleuropneumonia and a splenic infarction. aPT antibodies were transitorily detected. The patient recovered fully after antibiotic therapy and a 3-month course of anticoagulation treatment. Antiphospholipid (aPL) antibodies induced by acute infections have already been reported but cases of clinically relevant thrombosis remain rare. The pathogenicity of aPT antibodies is discussed here. We hypothesize that these antibodies were involved in this symptomatic hypercoagulable state.

[Continuous theoretical training in onco-hematology for pharmacy technician's working in cytotoxic preparation unit]. / Mise en place d'une formation continue théorique en onco-hématologie au sein d'une unité de préparation des anticancéreux.

OBJECTIVES: Within the context of pharmacy technician's (PT) continuing training (CT), a theoretical instruction in onco-hematology has been developed for PT working in our cytotoxic preparation unit (CPU). The aim of this study is to describe the approach taken, tools used and present knowledge assessment (KA). METHODS: A previous KA has been conducted using quiz available on GERPAC website which listing 36 drugs. Forty-five minutes sessions were conducted. KA was assessing before and after each session and 2 years after. PT appreciation was also evaluated. RESULTS: The previous KA served to targeting gaps and insisted on: indications, mechanism of action and cytotoxic drugs costs. Interactive sessions were led by a pharmacist and concerned about 17 diseases and 3 of the most prescribed cytotoxic drugs: 47 drugs summaries have been written by a pharmacist. The before-after knowledge improvement is significant (P>0.0005) (average [a] before=4.7 vs. a after=9.6). Two years after, this was non-significant but assessment results remain higher than before sessions (a=4.7 vs. 6.8). All PT wish sessions sustainability, 92% reported an adequate comprehension level. CONCLUSION: Lack of time and staff constitute a brake for sustaining and this was also highlighted by other units. Share this experience on a web platform could be interesting. Nevertheless, supports used during sessions should be suitable in conformity with the hospital practice and updated with new therapeutic.

[Implementation and assessment of anticancer drugs batch preparation circuit in a teaching hospital]. / Préparations hospitalières d'anticancéreux : mise en place et évaluation d'un circuit.

INTRODUCTION: In 2011, the anticancer preparation unit in a teaching hospital implemented a circuit for batch preparation of anticancer drugs. In this circuit, a manual and a semi-automatic production process coexist. The aim of the study is to describe the circuit in 2016 and to assess the impact of batch preparation in a anticancer preparation unit. MATERIAL AND METHODS: Eligible anticancer drugs for batch preparation satisfy two conditions: solution stability up to 28 days, prescription frequency up to one every two days. Batch worksheets are standardized. The pharmaceutical validation relies on the conformity of microbiological, analytical, gravimetric and visual controls of infusion bags. The duration of manual and semi-automatic batch preparation process and the time availability of an infusion bag were assessed. RESULTS: In 2016, eleven anticancer drugs (33 dosages) were eligible for batch preparation: it represents 22% of total production. In total, 70% was semi-automatic. The mean batch sizes were 27±9 (semi-automatic) and 14±1 (manual). The mean duration of production process was respectively 78min and 113min for semi-automatic and manual batch preparation. The mean time availability of an infusion bag was 32min±17. DISCUSSION AND CONCLUSION: Our process is secure. Batch preparation of anticancer drugs contributes to smooth production and spare nurses from preparing infusion bags outside opening hours of the anticancer preparation unit. Eligible anticancer drugs and batches size change constantly according to the evolution of prescription frequencies and anticancer drugs public tenders.

Is non-operative management of severe blunt splenic injury safer than embolization or surgery? Results from a French prospective multicenter study.

PURPOSE OF THE STUDY: The management of the severe blunt splenic injuries remains debated. The aim of this study is to evaluate the morbidity and mortality of splenic injury according to severity and management (surgery, embolization, non-operative management [NOM]). METHODS: A prospective multicenter study was conducted including patients aged 16 years and older with diagnosed splenic injury. We evaluated severity according to the AAST classification, the presence of hemoperitoneum or a contrast blush on initial CT scan. The initial hemodynamic status, patients co-morbidities, the ISS (injury severity score), management and morbidity were also noted. RESULTS: Between May 2010 and May 2012, 91 patients were included. Thirty-seven patients (41%) had mild splenic injury (AAST I or II and a small hemoperitoneum) while 54 patients (59%) had severe splenic injury (AAST III or greater). The management included 18 splenectomies (20%), 15 embolizations (16%). Among 67 patients undergoing NOM without initial embolization, five (7%) developed secondary bleeding, five required surgery and nine underwent secondary embolization. No patient died and morbidity was 44% (n=40), 13% for mild injuries vs. 65% for severe injuries (P<0.01). For severe injuries, total morbidity was 58% after NOM, 73% after embolization and 70% after surgery. Specific morbidity related to the management was 10% after NOM vs. 47% after embolization (P=0.02). Specific morbidity after surgery was 15%. CONCLUSION: Embolization, because of its important specific morbidity, should not be performed as a prophylactic measure, but only in presence of clinical or laboratory signs of bleeding.

Creation of a therapeutic digestive endoscopy suite in Senegal: renovation, training and university certification. Results of a Belgian-Senegalese inter-university project.

Therapeutic digestive endoscopy did not exist in sub-Saharan Africa before 2005. However, the prevalence of digestive diseases that could potentially benefit from basic endoscopic treatment is very high in this region. Portal hypertension with variceal bleeding and severe dysphagia associated with benign or malignant upper gastrointestinal tract diseases are prominent in these countries. The aim of the Project described in this report was to create a digestive endoscopy facility in Dakar (Senegal, West Africa), that would also provide local training in therapeutic endoscopy to doctors and nurses and facilitate regional autonomy with the opening of a University Certification in Gastroenterology. It took about 10 years to achieve these targets - 5 years to prepare realistic aims that took into account local needs, available local resources, and funding, and 4 years for the Project itself (2005-2009). At the present time, Senegalese colleagues and nurses are autonomous for basic therapeutic procedures in the upper and lower gastrointestinal tract. Two years after the end of funding, the rate of therapeutic activity has increased from 0% in 2005 to 12 % of digestive endoscopic activity in 2011. Key points of success were preparation, confidence of medical personnel, university involvement, shared funding, local multidisciplinary training, and facilitation of autonomy. Belgian healthcare workers were present on-site in Dakar for a total of about 6 months over the 4-year Project period, with an annual budget of less than € 80000. The Project has enabled an efficient North-South collaboration with a minimal budget, which has changed the healthcare provision of digestive endoscopy in Senegal, and has also provided autonomy, and facilitated the development of South-South cooperation.

Splenic injury: management in the Languedoc-Roussillon region.

GOAL OF STUDY: Treatment of splenic injury is not standardized. We conducted an inventory of splenic injury treatment modalities of splenic injury in the Languedoc-Roussillon region of France. METHODS: A questionnaire was sent by e-mail to 33 surgeons practicing in 10 hospitals in that region. Surgeons were asked: how many cases were treated per year (PMSI databank for the last three years), local resources (resuscitation bay or intensive care unit, availability of CT and interventional radiology), indications (surgery, embolization, nonoperative management [NOM]), prognostic criteria, NOM modalities (duration of bed rest, hospital stay, restriction of physical activity, thromboembolic prophylaxis, and imaging schedule). RESULTS: Thirty-one surgeons replied. An average of 185 patients were treated per year. There was consensus concerning the indication for urgent splenectomy, NOM was practiced in the stable patient (even with diffuse hemoperitoneum) and splenic artery embolization was performed for active bleeding (blush on CT) (for the six centers who have interventional radiology at their disposal). Disparities existed between centers concerning the modalities of NOM excepting imaging monitoring, initial surveillance in resuscitation bay or intensive care and in the therapeutic indications when bleeding persisted. CONCLUSION: Based on the consensus observed in this study and an analysis of the literature, a uniform treatment policy can be proposed.

Factors and consequences of conversion in laparoscopic sigmoidectomy for diverticular disease.

BACKGROUND: The disadvantages of laparoscopic elective sigmoidectomy for diverticular disease include the risk of conversion to open operation and longer operative time. The aim of this study was to analyse the causes and consequences of conversion in 168 consecutive patients who underwent a laparoscopically assisted colectomy between January 1994 and June 2001. METHODS: Data were collected prospectively to analyse the causes and consequences of conversion to open surgery in terms of postoperative morbidity and patient recovery. RESULTS: Postoperative mortality, morbidity, conversion and reoperation rates were zero, 21.4 per cent (n = 36), 14.3 per cent (n = 24) and 3.0 per cent (n = 5) respectively. The reasons for conversion were presence of intraperitoneal adhesions and/or inflammatory pseudotumour (n = 21), an intraoperative diagnosis of sigmoid cancer (n = 1), hypercapnia (n = 1) and abdominal bleeding (n = 1). Three preoperative factors were associated with a significant higher risk of conversion: surgical expertise, the presence of sigmoid stenosis or fistula, and the severity of diverticulitis on pathological examination. Morbidity was no different between laparoscopic sigmoidectomy (30 of 144; 20.8 per cent) and converted procedures (six of 24; 25.0 per cent). Open conversion was associated with a longer operative time and significantly delayed patient recovery and hospital discharge. CONCLUSION: Surgical experience and severe diverticular disease are predictive factors for conversion in laparoscopic elective sigmoidectomy. Even if necessary, conversion does not increase the morbidity rate.

[Treatment of common bile duct stones with laparoscopy. Retrospective multicenter study with 612 patients]. / Traitement de la lithiase de la voie biliaire principale sous laparoscopie. Etude rétrospective multicentrique chez 612 malades.

OBJECTIVE: To analyse retrospectively the results of one-stage laparoscopic treatment for common bile duct stones in 19 surgical centers in France. PATIENTS: From January 1991 to July 1996, 612 patients with choledocholithiasis underwent laparoscopic treatment. RESULTS: Overall duct clearance was obtained in 489 of the 612 patients (80%): through the cystic duct in 222 of 380 patients (58.4%), by secondary choledochotomy (after unsuccessful transcystic duct extraction) in 77 of 96 (80%), and in 190 of 232 (82 %) by primary choledochotomy. The overall duct clearance rate increased from 65% in 1991 to 84% in 1996. The use of the choledochotomy approach increased from 43% in 1991 to 69% in 1996 (P<0.01), due to a substantial increase in primary choledochotomy. In contrast, the use of the transcystic approach decreased from 57% to 31% (P<0.01). The mean time for surgery was shorter for cystic duct exploration than for primary choledochotomy (101+/-51 vs. 155+/-62 min, P<0.0001). The mean hospital stay decreased from 7.7+/-3.6 days in 1991 to 4.1+/-2 days in 1996 (P<0.001). The main biliary complications were related to biliary drainage (2,8%) and retained stones (3.1%). CONCLUSION: This study confirms that laparoscopy is a good alternative with a low complication rate, a short hospital stay, and is an effective and safe option for the management of common bile duct stones.

Specific vascular complications of orthotopic liver transplantation with preservation of the retrohepatic vena cava: review of 1361 cases.

OBJECTIVE: The objective of this study was to describe the complications specifically related to orthotopic liver transplantation (OLT) with preservation of the inferior vena cava and to their therapeutic management. This preservation technique has considerably influenced the surgical phases of liver transplantation, increasing hepatectomy time and modifying the number of vascular anastomoses. METHODS: Our retrospective multicentric study, based on data from 1361 adult patients that had undergone orthotopic liver transplantation with preservation of the inferior vena cava in France between 1991 and 1997, analyzed the concomitant surgical complications. Type of cavo-caval anastomosis performed (piggyback, end-to-side, or side-to-side), use of a temporary portacaval anastomosis, technique-related complications, and mortality, were investigated. RESULTS: Cavo-caval anastomosis was side-to-side in 50.6% of cases (n=689), piggyback in 42.7% (n=582), and end-to-side in 6.6% (n=90). In total, 882 temporary portacaval anastomosis were carried out. Fifty-five patients presented with one or more complications related to the preservation of the inferior vena cava technique; i.e., overall morbidity was 4.1% (55/1361). Overall mortality was 0.7% (10/1361). Mortality rate for patients who presented with surgical complication was 18%. A total of 64 complications were recorded: 57 (89%) were in the perioperative or immediate postoperative period and 7 (11%) were postoperative. CONCLUSIONS: These retrospective, descriptive results show significant advantages in favor of side-to-side anastomosis in terms of vascular complications. Certain factors should be evaluated specifically at pretransplant assessment to prevent certain serious complications; principally, these are anatomic factors of the recipient (inferior vena cava included in segment I, anatomic abnormalities of the inferior vena cava) and graft size. Depending on these factors, surgeons must be able to adapt the orthotopic liver transplantation, either before or during orthotopic liver transplantation, preferring the standard technique.

Experimental assessment of the risk of tumor recurrence after laparoscopic surgery.

BACKGROUND: The aim of this experimental study was to evaluate the risk of tumor recurrence after laparoscopic cecal resection (LCR) of colonic carcinoma in the rat. METHODS: The experimental cancer consisted of one million cells (DHK/K12), incorporated in an extracellular matrix, placed and secured to the cecal serosa in 110 BD9 rats. Four weeks later, all animals were reoperated through a laparotomy to control tumor growth, and animals with diffuse carcinomatosis were excluded. Eligible animals were randomized either to laparoscopic cecal resection (group LCR, n = 10), to open resection (group OCR, n = 13), or to a control group without resection (group C, n = 13). Resection was always considered as macrocopically complete. All animals were killed 4 weeks after the resection to determine the tumor recurrence and quantify carcinomatosis. RESULTS: We noted diffuse carcinomatosis in 70% of rats in groups C and LCR versus 23% in group OCR (p = 0.038). For tumors noted as S- (not extending outside the serosa), diffuse carcinomatosis was observed in all animals of group C (3 of 3), in 6 of 8 in group LCR, and 0 of 6 in group OCR (p = 0.004). The rate of port site or incisional metastases was not significantly different between groups. CONCLUSIONS: These preliminary results demonstrated the deleterious impact of the laparoscopy for resection of large bowel malignancy. LCR increased significantly the incidence of a diffuse carcinomatosis even when performed for locally noninvasive tumors (S-).