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

Robot-assisted pelvic floor reconstructive surgery:an international Delphi study of expert users

Background: Robotic surgery has gained popularity for the reconstruction of pelvic floor defects. Nonetheless, there is no evidence that robot-assisted reconstructive surgery is either appropriate or superior to standard laparoscopy for the performance of pelvic floor reconstructive procedures or that it is sustainable. The aim of this project was to address the proper role of robotic pelvic floor reconstructive procedures using expert opinion. Methods: We set up an international, multidisciplinary group of 26 experts to participate in a Delphi process on robotics as applied to pelvic floor reconstructive surgery. The group comprised urogynecologists, urologists, and colorectal surgeons with long-term experience in the performance of pelvic floor reconstructive procedures and with the use of the robot, who were identified primarily based on peer-reviewed publications. Two rounds of the Delphi process were conducted. The first included 63 statements pertaining to surgeons’ characteristics, general questions, indications, surgical technique, and future-oriented questions. A second round including 20 statements was used to reassess those statements where borderline agreement was obtained during the first round. The final step consisted of a face-to-face meeting with all participants to present and discuss the results of the analysis. Results: The 26 experts agreed that robotics is a suitable indication for pelvic floor reconstructive surgery because of the significant technical advantages that it confers relative to standard laparoscopy. Experts considered these advantages particularly important for the execution of complex reconstructive procedures, although the benefits can be found also during less challenging cases. The experts considered the robot safe and effective for pelvic floor reconstruction and generally thought that the additional costs are offset by the increased surgical efficacy. Conclusion: Robotics is a suitable choice for pelvic reconstruction, but this Delphi initiative calls for more research to objectively assess the specific settings where robotic surgery would provide the most benefit.</p

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

Neuromodulation des racines sacrées pour double incontinence fécale et urinaire (résultats fonctionnels des patients traités au CHU de Grenoble)

INTRODUCTION: La neuromodulation des racines sacrées est une technique validée dans les traitements des incontinences urinaire et fécale. Peu d'études évaluent les résultats sur la double incontinence urinaire et fécale. L'objectif de notre étude est d'évaluer les résultats fonctionnels des patients traités par neuromodulation pour une double incontinence urinaire et fécale, au CHU de Grenoble. MATERIEL ET METHODES: 56 patients ont été inclus, présentant tous une double incontinence urinaire et fécale. Les implantations de neuromodulateurs ont eu lieu entre janvier 2001 et mars 2010, par deux opérateurs. Les patients ont été évalués par des questionnaires score symptômes (Wexner, Urinary Symptom Profile) et qualités de vie (Fecal Incontinence Quality of Life, Ditrovie), qui leur ont été envoyés par courrier. Une enquête téléphonique a également été conduite pour une évaluation numérique de la satisfaction des patients quant au traitement. RESULTATS: L'incontinence fécale est sévère dans la population (en moyenne 14,1/20) et significativement améliorée par la neuromodulation des racines sacrées (en moyenne 7,2/20). L'incontinence urinaire, principalement par urgenturie (47%) ou mixte (34%), est améliorée significativement sauf pour le critère d'incontinence à l'effort et le versant dysurie. La qualité de vie spécifique est améliorée pour l'incontinence urinaire et pour l'incontinence fécale. L'échelle numérique retrouve 73% de patients globalement satisfaits et 9% de patients détériorés par la neuromodulation des racines sacrées. Le taux de ré-intervention est de 29%, dont 12% de complications, principalement des douleurs. CONCLUSION: Malgré le caractère rétrospectif de notre série, il semble que la neuromodulation des racines sacrées soit un traitement efficace et sûr de la double incontinence urinaire et fécale.INTRODUCTION: Sacral nerve stimulation is a validated technique to treat both fecal and urinary incontinence. Only few studies report results in double incontinence. Our study aims to evaluate functionnal results of patients treated in Grenoble for a double incontinence (fecal and urinary). MATERIALS AND METHODS: 56 patients were included, all suffering from double incontinence. Surgical procedures were performed between january 2001 and march 2010, by two surgeons. Patients were evaluated with score symptoms questionnaires (Wexner, Urinary Symptom Profile) and quality of life questionnires (Fecal Incontinence Quality of Life, Ditrovie), that we sent to them by mail. A telephonic consulting was also leaded to evaluate with numeric scale patient's satisfaction about sacral nerve stimulation. RESULTS: Fecal incontinence is severe in our population (average 14,1/20) and significantly better after sacral nerve stimulation (average 7,2/20). Urinary incontinence, mostly urgency incontinence (47%) or mixte (34%), improved significantly except for stress incontinence and dysuria. Specific quality of life improve for both fecal and urinary incontinence. Numeric scale show 73% satisfied patients and 9% of patients feeling deteriorate with sacral nerve stimulation. Rate of reintervention is 29%, among wich 12% of complications, mostly pain. CONCLUSION: Although our study is retrospective, it seems that sacral nerve stimulation is an effective and safe treatment for double incontinence (fecal and urinary incontinence).GRENOBLE1-BU Médecine pharm. (385162101) / SudocSudocFranceF

Rectopexie coelioscopique pour prolapsus rectal (étude prospective à propos de 54 cas consecutifs)

Plus de trois cents techniques chirurgicales ont été proposées dans le traitement du prolapsus du rectum. Les rectopexies abdominales sont les plus efficaces mais sont génératrices de constipation et de dyschésie post-opératoires dans environ un cas sur deux. Le but de cette thèse a été d'étudier prospectivement les résultats fonctionnels d'une rectopexie coelioscopique dérivée de la promontofixation selon Orr-Loygue. Les données per-opératoires et post-opératoires précoces confirment les bénéfices à court terme de la laparoscopie, concernant notamment la réduction des douleurs et une réhabilitation plus rapide. A long terme, les taux de récidive et d'amélioration de la continence sont semblables à ceux observés après rectopexie par laparotomie mais notre technique, par une dissection plus limitée et une fixation du matériel sur la paroi antérieure du rectum, génère moins de constipation et de dyschésie post-opératoires, comme le confirment les données des défécographies dynamiques pré- et post-opératoires systématiques.GRENOBLE1-BU Médecine pharm. (385162101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

Cancers coliques en occlusion (Evaluation rétrospective de la prise en charge sur une période de 10 ans)

BESANCON-BU Médecine pharmacie (250562102) / SudocSudocFranceF

Place de la déféco-IRM et du viscérogramme pelvien dans les troubles de la statique pelvienne postérieure chez la femme

But de l'étude : définir la place de la déféco-IRM et du viscérogramme pelvien afin de permettre une prise en charge chirurgicale optimale des prolapsus pelviens postérieurs. Matériels et méthodes : étude prospective, en aveugle, débutée en mai 2006, dans le service de chirurgie colorectale du CHU de Grenoble. Rapport d'étape après inclusion de 45 patientes. Analyse statistique des sensibilités, spécificités, VPP, VPN, de la concordance et du coefficient kappa de l'examen clinique, de la déféco-IRM et du viscérogramme pelvien. Résultats : le prolapsus rectal extériorisé isolé est d'un diagnostic clinique (sensibilité 100%, kappa=1). La déféco-IRM est peu sensible (43%) en raison d'une position moins physiologique. Pour la colpocèle postérieure, l'examen clinique fait le diagnostic (sensibilité 94%, kappa=0,78) mais ne peut faire celui de son contenu puisqu'il est pris en défaut une fois sur deux. Pour le diagnostic d'élytrocèle, le viscérogramme reste supérieur à la déféco-IRM (sensibilité 80%, kappa=0,72 versus sensibilité 63% et kappa=0,54). Quant au prolapsus rectal interne, le viscérogramme marque également sa supériorité. Discussion : l'examen clinique reste insuffisant pour le diagnostic complet des prolapsus pelviens postérieurs surtout lorsqu'ils sont complexes. Pour permettre une prise en charge optimale, nous avons besoin d'un examen complémentaire et l'analyse intermédiaire de notre étude nous fait préférer la réalisation d'un viscérogramme. Conclusion : la pelvipérinéologie est une discipline récente qui doit intéresser tous les acteurs médicaux pour permettre de bien prendre la en charge. Même si le viscérogramme garde une place privilégiée, la déféco-IRM progresse et devrait prendre une place grandissante.GRENOBLE1-BU Médecine pharm. (385162101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

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

Hedrocele Associated With Full-Thickness Rectal Prolapse

International audienc