Retour d'expérience sur la mise en place du Lean dans un centre de Radiothérapie

International audienceL'amélioration de l'efficience des organisations est aujourd'hui un enjeu majeur des établissements de santé, qui doivent fournir des soins de haute qualité aux patients tout en réduisant les coûts et en maintenant une atmosphère de travail agréable pour le personnel. Dans ce papier nous présentons comment les principes du Lean management ont été utilisés et adoptés par un centre de radiothérapie français pour améliorer son efficience dans le traitement de certains cancers. Nous discutons ensuite des bonnes pratiques en terme de déploiement du Lean en santé

Biomechanical behaviour of human bile duct wall and impact of cadaveric preservation processes.

International audienceBiliary diseases are the third most common cause of surgical digestive disease. There is a close relationship between the mechanical performance of the bile duct and its physiological function. Data of biomechanical properties of human main bile duct are scarce in literature. Furthermore, mechanical properties of soft tissues are affected by these preservation procedures. The aim of the present work was, on the one hand, to observe the microstructure of the human bile duct by means of histological analysis, on the other hand, to characterize the mechanical behavior and describe the impact of different preservation processes. A mechanical study in a controlled environment consisting of cyclic tests was made. The results of the mechanical tests are discussed and explained using the micro-structural observations. The results show an influence of the loading direction, which is representative of an anisotropic behavior. A strong hysteresis due to the viscoelastic properties of soft tissues was also observed. Embalming and freezing preservation methods had an impact on the biomechanical properties of human main bile duct, with fiber network deterioration. That may further provide a useful quantitative baseline for anatomical and surgical training using embalming and freezing

Development of a Connected Sensor System in Colorectal Surgery:User-Centered Design Case Study

BACKGROUND: A successful innovative medical device is not only technically challenging to develop but must also be readily usable to be integrated into health care professionals’ daily practice. Through a user-centered design (UCD) approach, usability can be improved. However, this type of approach is not widely implemented from the early stages of medical device development. OBJECTIVE: The case study presented here shows how UCD may be applied at the very early stage of the design of a disruptive medical device used in a complex hospital environment, while no functional device is available yet. The device under study is a connected sensor system to detect colorectal anastomotic leakage, the most detrimental complication following colorectal surgery, which has a high medical cost. We also aimed to provide usability guidelines for the initial design of other innovative medical devices. METHODS: UCD was implemented by actively involving health care professionals and all the industrial partners of the project. The methodology was conducted in 2 European hospitals: Grenoble-Alpes University Hospital (France) and Erasmus Medical Center Rotterdam (the Netherlands). A total of 6 elective colorectal procedures and 5 ward shifts were observed. In total, 4 workshops were conducted with project partners and clinicians. A formative evaluation was performed based on 5 usability tests using nonfunctional prototype systems. The case study was completed within 12 months. RESULTS: Functional specifications were defined for the various components of the medical device: device weight, size, design, device attachment, and display module. These specifications consider the future integration of the medical device into current clinical practice (for use in an operating room and patient follow-up inside the hospital) and interactions between surgeons, nurses, nurse assistants, and patients. By avoiding irrelevant technical development, this approach helps to promote cost-effective design. CONCLUSIONS: This paper presents the successful deployment over 12 months of a UCD methodology for the design of an innovative medical device during its early development phase. To help in reusing this methodology to design other innovative medical devices, we suggested best practices based on this case

Developpment and evaluation of a Global Vision System for Laparoscopic Surgery

La laparoscopie est apparue comme une alternative révolutionnaire à la chirurgie conventionnelle par laparotomie à partir des années 1990. L'opérateur réalise alors la chirurgie à l’aide d’instruments fins dédiés insérés par des trocarts (cylindres étanches traversant la paroi abdominale) mesurant 5-10mm. Une caméra est insérée dans l'abdomen et un écran situé devant le chirurgien affiche l'image des organes à opérer. Cette révolution technique présente un réel bénéfice post-opératoire pour patient avec des durées d’hospitalisation et réhabilitations plus courtes. Néanmoins elle s’accompagne d’un inconfort pour le chirurgien, en partie lié à la perte de la vision de l’ensemble de la cavité abdominale et l’apparition de zones aveugles visibles en chirurgie conventionnelle ouverte.Ce travail de thèse s’adresse à cette problématique. Nous avons développé un Système de Vision Globale (SVG) permettant d’élargir le champ de vision de la cœlioscopie et de réduire les zones aveugles. Le SVG est un trocart optique innovant sur lequel 2 micro caméras sont déployées tout en permettant l’insertion de l’endoscope classique. Le projet a été réalisé au sein du laboratoire Techniques de l'Ingénierie Médicale et de la Complexité, dans l'équipe Gestes Médico-Chirurgicaux Assistés par Ordinateur, sous la responsabilité du Dr Sandrine Voros, dans le cadre du projet ANR DEPORRA 2 et du projet « LabCom » ANR CQFD en collaboration avec la société SurgiQual Institute (SQI).La première partie décrit le bénéfice et les contraintes de la laparoscopie comme voie d'abord pour les procédures chirurgicales. Un état de l’art au sujet des innovations technologiques permettant d'améliorer certains inconvénients de cette voie d'abord est réalisé. Le contexte clinique, dans lequel le SVG a été développé, est décrit.La seconde partie aborde les aspects techniques du SVG. Le cahier des charges et les objectifs cliniques sont définis. Nous détaillons les problématiques rencontrées et les différents prototypes conçus qui ont permis d'aboutir à l'évaluation du SVG sur cadavre et sur cochons. Cette phase a été réalisée en collaboration avec la société SQI dans le cadre du projet LabCom CQFD, permettant ainsi de prendre en compte dès le début du projet les contraintes de compatibilité clinique des prototypes.La troisième partie expose l'évaluation du SVG sur banc d'essai laparoscopique sec en se basant sur les objectifs cliniques définis. Trois expérimentations ont eu lieu sur des populations différentes (novices et experts). Un simulateur et des exercices spécifiques ont été développés à cet effet. L’évaluation a permis de montrer que le SVG permettait la détection précoce d’un évènement indésirable sans augmentation du temps de réalisation ou de la charge mentale.La quatrième partie développe l'expérimentation sur cadavre et cochons réalisée à l'aide de chirurgiens experts sur des compétences chirurgicales complexes, qui fait suite aux résultats obtenus sur banc d'essai sec. Après une phase de test des différentes versions des prototypes, une étude de la sécurité d’utilisation a pu être faite. La preuve de concept a pu être démontrée sur modèle porcin vivant. L'intérêt clinique a, donc, pu être évalué sur un modèle animal au plus proche des conditions de la réalité clinique humaine. Les débriefings des différents experts ont été favorables et ont permis d’identifier les points d’amélioration nécessaires dans le futur.Le SVG, à son stade de prototype, a pu être efficacement testé chez le vivant. La maturation du prototype sur les aspects sécuritaires, notamment électroniques et de stérilisation, permettra de proposer les premiers tests chez l’humain.In the 1990s, laparoscopic surgery was developed as a revolutionary alternative to conventional laparotomy surgery. The operator can perform the surgery using dedicated instruments inserted by trocars (sealed cylinders introduced through the abdominal wall) measuring 5 -10mm. A camera is inserted into the abdomen and a screen in front of the surgeon displays the image of the organs that need to be operated. This technical revolution has a real postoperative benefit for patients with shorter hospitalization and rehabilitation periods. Nevertheless it is accompanied by discomfort for the surgeon, partly related to the loss of vision of the entire abdominal cavity and the appearance of blind spots that are visible in conventional open surgery.This thesis work addresses this problem. We have developed a Global Vision System (GVS) to expand the field of view of laparoscopy and reduce blind areas. GVS is an innovative optical trocar on which 2 micro cameras are deployed and allow the insertion of the usual endoscope. The project was carried out in the Laboratory of Medical Engineering and Complexity (TIMC), in the Computer Assisted Medico-Surgical Gestures team (GMCAO), under the responsibility of Dr. Sandrine Voros, as part of the ANR DEPORRA 2 project and the "LabCom" project ANR CQFD in collaboration with SurgiQual Institute (SQI).The first part describes the benefit and constraints of laparoscopy for surgical procedures. A state of the art about technological innovations to improve certain disadvantages of this approach is provided. The clinical context of the GVS is given.The second part deals with the technical aspects of GVS. The specifications and the clinical objectives are defined. We detail the problems encountered during the development and the different prototypes designed that led to the evaluation of GVS on cadaver and pigs. This phase was carried out in collaboration with SQI as part of the LabCom CQFD pt, thus making it possible to take into account, from the beginning of the project, the constraints of clinical compatibility of the prototypes (sterilization, electrical compatibility, etc).The third part describes the evaluation of GVS on dry laparoscopic test bench based on the defined clinical objectives. Three experiments took place on different populations (novices and experts). A simulator and specific exercises have been developed for this purpose. The evaluation showed that GVS allowed the early detection of an adverse event without increasing the time of completion or the mental load.The fourth part develops the experiment on cadaver and pigs carried out with the help of surgeons experts on complex surgical skills, which follows the results obtained on dry test bench. After a test phase of the different versions of the prototypes, a study of the safety of use could be made. The proof of concept could be demonstrated on live porcine model. Thus, the clinical interest could be evaluated on an animal model closer to the conditions of real human surgery. The debriefings of the various experts were favorable and helped to identify the points of improvement necessary in the future.The GVS prototype has been effectively tested in live model. The maturation of the prototype on the security aspects, in particular electronic, and sterilization, will make it possible to pursue the first human tests

Surgical treatment for defaecation disorders.

International audienceSurgical treatment for defaecation disorders. Defaecation disorder that resists to conservative management can be treated surgically, if morphologic pelvic disorders are demonstrated. Most authors perform laparoscopic ventral rectopexy to the promontory to treat internal rectal prolapse, full-thickness rectal prolapse and/ or rectocele. A perineal or perineo vaginal approach is proposed in some cases of patients presenting with a rectocele, where an abdominal approach is impossible or difficult (severe adhesions), or when general anaesthesia is contra-indicated. For the same reasons, a perineal approach is performed in patients with full-thickness rectal prolapse, either a Delorme or an Altemeier procedure. As North American authors, we think that a stapled trans anal rectal resection, or STARR procedure, in order to treat an internal rectal prolapse or a rectocele does not help patient to be proposed routinely: there is still a place for the Sullivan procedure, namely in male patients with internal rectal prolapse

Improving care efficiency in a radiotherapy center using Lean philosophy

International audienceIn the field of health care, as in production or services, there is a need for tailor made methodology to help managers improving quality of care as well as efficiency of the organization. Quality Improvement (QI) has become a major preoccupation in the current context where hospitals and health care services need to provide a high level of care and a welcoming environment for patients while reducing costs and maintaining a pleasant work atmosphere for staff. In this paper we present how, with very few adaptation to the local culture, the principles of Lean Thinking combined to the well known DMAIC from Six-Sigma can be applied to improve the efficiency of a French therapy center for cancer treatment. We then discuss how this methodology could be generalized to a larger structure such as a teaching hospital

Surgical treatment for defaecation disorders.

International audienceSurgical treatment for defaecation disorders. Defaecation disorder that resists to conservative management can be treated surgically, if morphologic pelvic disorders are demonstrated. Most authors perform laparoscopic ventral rectopexy to the promontory to treat internal rectal prolapse, full-thickness rectal prolapse and/ or rectocele. A perineal or perineo vaginal approach is proposed in some cases of patients presenting with a rectocele, where an abdominal approach is impossible or difficult (severe adhesions), or when general anaesthesia is contra-indicated. For the same reasons, a perineal approach is performed in patients with full-thickness rectal prolapse, either a Delorme or an Altemeier procedure. As North American authors, we think that a stapled trans anal rectal resection, or STARR procedure, in order to treat an internal rectal prolapse or a rectocele does not help patient to be proposed routinely: there is still a place for the Sullivan procedure, namely in male patients with internal rectal prolapse

Impact of the Primary Tumor Location on the Prognosis for Colon Cancer

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Erosion Rate of the Magnetic Sphincter Augmentation Device Is Much Higher for Anal Incontinence than for Antireflux

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Comment on “What Expert Surgeons Never Tell You About Robot-assisted Surgery for Rectal Cancer?”

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