Robot-assisted laparoscopy for deep infiltrating endometriosis: a retrospective French multicentric study (2008-2019) using the Society of European Robotic Gynecological Surgery endometriosis database.

OBJECTIVE: This study aimed at assessing perioperative results of robot-assisted laparoscopy (RAL) in the context of deep infiltrating endometriosis (DIE). METHODS: This retrospective French multicentric study included all patients with DIE who underwent surgical treatment managed by RAL (Da Vinci® System). From November 2008 to June 2019, patients were included in a single European database, in Robotic Assisted Laparoscopic Gynecologic Surgery, with Society of European Robotic Gynecological Surgery collaboration. Patients had different DIE sites as follows: gynecological, urological, or digestive, or combinations of these. Surgical procedures and perioperative complications were evaluated. To assess complications, patients were divided into the following four groups according to surgical procedure and DIE site: gynecological only; gynecological and urological; gynecological and digestive; and gynecological, urological, and digestive. RESULTS: A total of 460 patients treated at one of eight health-care facilities from November 2008 to June 2019 were included. Median operative time was 245 min (IQR 186-320), surgeon console time was 138 ± 75 min and estimated blood loss was 70.0 mL ± 107 mL. Among this patient sample, 42.1% had a multidisciplinary surgical approach with a digestive or urology surgeon in addition to gynecology surgeon (25.5% and 16.6% of cases, respectively). Among those with intraoperative complications (n = 25, 5.4%) were primarily conversion to laparotomy (n = 6, 2.0%), transfusion (n = 2, 0.6%), and organ wounds (n = 8, 1.7%). Overall, 5.6% had severe postoperative complications (Clavien-Dindo classification ≥ Grade 3). CONCLUSION: This is among the largest published series addressing RAL for DIE. Interest in this procedure appears promising, with no observed increases in blood loss or in peri- or post-operative complications. DIE laparoscopic surgery can require complex surgical procedures performed by multidisciplinary surgical teams. Thus, it may be one of the best candidates for RAL within gynecology surgery.

[Feasibility and security of laparoscopic (± robotic) total hysterectomy in outpatient surgery: A French multicenter retrospective study]. / Faisabilité et sécurité de l'hystérectomie totale par voie cœlioscopique (± robot assisté) en chirurgie ambulatoire : une étude rétrospective multicentrique française.

OBJECTIVE: To assess the feasibility and safety of total hysterectomy by laparoscopic approach (± robot assisted) in ambulatory. MATERIALS AND METHODS: French three-center retrospective study including 165 patients who had laparoscopic (± robot assisted) total hysterectomy scheduled as outpatients from January 2016 to December 2020. Clinical and perioperative data were collected. Factors associated with outpatient failure and rehospitalization were evaluated. RESULTS: The outpatient success rate was 92.7%. Factors associated with outpatient failure were incision time>13:00, large volume of blood loss, intraoperative complications with Oslo score≥2, uterine weight≥250g, indication for benign pathology, and robot-assisted approach. Among patients managed as outpatients, 7.2% were rehospitalized at a mean of 10 days from surgery. The factors associated with rehospitalization were the use of an effective antiaggregant or anticoagulant treatment and the use of intraoperative adhesiolysis. Four patients (2.6%) underwent revision surgery. CONCLUSION: Minimally invasive hysterectomy can be performed as an outpatient procedure even in cases of malignant pathology. Age and body mass index are not associated with an increased risk of failure or re-hospitalization within one month.

Supporting innovation in health care: A short experience in a dedicated unit of the French Ministry of Public Health.

INTRODUCTION: The Delegation for Innovation in Health Care (DIES) was created by the Ministry of Solidarity and Health to centralize and support innovative health care projects. Following its dissolution, only two and a half years after its creation, the members of this delegation aimed to present the projects, which were submitted and treated by the DIES. METHODS: All potential project leaders were free to explain the objectives of their project to our team. These projects were then classified according to their objective, their type, the medical specialty concerned, the target population and their purpose. The DIES graded the degree of innovation, advised on the need for complementary scientific evaluation and oriented the personnel in charge towards fitting financing structures. RESULTS: Between April 2016 and December 2018, the DIES received 269 potential project leaders, almost exclusively from the national territory of France, focused on diversified medical specialties with a slight predilection for chronic diseases and disabilities. The projects were often at an economically tenuous stage of development. Less than 5% of the projects concerned drug therapy. More than a third involved medical devices, including "surgical" projects (predominately orthopedics), disability compensation methodology, vascular problems and bandages. E-health, the organization of care, and a "non-classifiable" category that included wellness projects each represented 20% of the projects. Almost 80% of these projects had some electronically (e-) based mechanism. Only 15% of all projects had the ambition to meet an unmet or poorly covered need. Only about a third of the project leaders presented a clinical or medico-economic evaluation with sufficiently rigorous methodology to assess the achievement of their objectives. CONCLUSION: Innovative health projects are dominated by the search for improvement in the organization of the health care system and the care pathway with e-connected applications. Evaluation of the vast majority of these projects is very difficult and this situation reinforces the idea that these requests should be centralized to improve support for promoters of innovation.

Prevention of biliary fistula after partial hepatectomy by transcystic biliary drainage: randomized clinical trial.

BACKGROUND: Biliary fistula is one of the most common complications after hepatectomy. This study evaluated the effect of transcystic biliary drainage during hepatectomy on the occurrence of postoperative biliary fistula. METHODS: This multicentre RCT was carried out from 2009 to 2016 in nine centres. Patients were randomized to transcystic biliary drainage or no transcystic drainage (control). Patients underwent hepatectomy (more than 2 segments) of non-cirrhotic livers. The primary endpoint was the occurrence of biliary fistula after surgery. Secondary endpoints were morbidity, postoperative mortality, duration of hospital stay, reoperation, readmission to hospital, and complications caused by catheters. Intention-to-treat and per-protocol analyses were performed. RESULTS: A total of 310 patients were randomized. In intention-to-treat analysis, there were 158 patients in the transcystic group and 149 in the control group. Seven patients were removed from the per-protocol analysis owing to protocol deviations. The biliary fistula rate was 5·9 per cent in intention-to-treat and 6·0 per cent in per-protocol analyses. The rate was similar in the transcystic and control groups (5·7 versus 6·0 per cent; P = 1·000). There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000). Median duration of hospital stay was longer in the transcystic group (11 versus 10 days; P = 0·042). The biliary fistula risk was associated with the width and length of the hepatic cut surface. CONCLUSION: This randomized trial did not demonstrate superiority of transcystic drainage during hepatectomy in preventing biliary fistula. The use of transcystic drainage during hepatectomy to prevent postoperative biliary fistula is not recommended. Registration number: NCT01469442 ( http://www.clinicaltrials.gov).

ANTECEDENTES: La fístula biliar es una de las complicaciones más comunes después de la hepatectomía. Este estudio evalúa el efecto del drenaje biliar transcístico durante la hepatectomía en la aparición de una fístula biliar postoperatoria. MÉTODOS: Este ensayo prospectivo aleatorizado y multicéntrico (Clinical Trial NCT01469442) con dos grupos de estudio (grupo transcístico versus grupo control) se llevó a cabo de 2009 a 2016 en 9 centros. Los pacientes fueron sometidos a una hepatectomía (≥ 2 segmentos) en hígados no cirróticos. El resultado principal fue la aparición de una fístula biliar después de la cirugía. Los resultados secundarios fueron la morbilidad, la mortalidad postoperatoria, la duración de la estancia hospitalaria, la reintervención, la necesidad de reingreso y las complicaciones causadas por los catéteres. Se realizaron análisis por intención de tratamiento y por protocolo. RESULTADOS: Un total de 310 pacientes fueron randomizados. Por intención de tratamiento, 158 pacientes fueron aleatorizados al grupo transcístico y 149 al grupo control. Siete pacientes fueron excluidos del análisis por protocolo por desviaciones del protocolo. La tasa de fístula biliar fue del 5,9% en el análisis por intención de tratamiento y del 6,0% en el análisis por protocolo. Esta tasa fue similar para el grupo transcístico y para el grupo control: 5,7% versus 6,0% (P = 1). No hubo diferencias en términos de morbilidad (49,4% versus 46,9%, P = 0,731), mortalidad (2,5% versus 4,7%, P = 0,367) y reintervenciones (4,4% versus 10,1%, P = 1). La mediana de la duración de la estancia hospitalaria fue mayor para el grupo transcístico (11 versus 10 días, P = 0,042). El riesgo de fístula biliar se correlacionó con el grosor y la longitud de la transección hepática. CONCLUSIÓN: Este ensayo aleatorizado no demuestra la superioridad del drenaje transcístico durante la hepatectomía para prevenir la fístula biliar. No se recomienda el uso de drenaje transcístico durante la hepatectomía para prevenir la fístula biliar postoperatoria.

[For which patients could we consider de-escalation in the management of ductal carcinomas in situ?] / Pour quelles patientes peut-on envisager une désescalade dans la prise en charge des carcinomes canalaires in situ ?

Ductal carcinomas in situ (DCIS) of the breast account for 85% to 90% of breast cancer in situ. Current recommendations for the management of DCIS in France are based on surgical excision of the lesions, lumpectomy in healthy margins (margins of excision≥2mm) or mastectomy in case of extensive lesions. Radiation therapy is recommended after conservative surgical treatment. However, it seems relevant for some patients to discuss the benefit of a therapeutic de-escalation. Indeed, it has been reported that radiotherapy has no major impact on overall survival and that its interest could be discussed in the low-risk situations of invasive recurrence for which surgery alone could be sufficient, subject to sufficient margins. These questions call for the precise definition of low risk populations and to clarify the importance of taking into account decision support tools and new molecular markers. The place of scores like that of the University of Southern California - Van Nuys, and that of genomic tests such as the Oncotype test© DX DCIS (DCIS score) need to be specified. The expected results of several prospective studies could go in the direction of a significant therapeutic de-escalation for the management of DCIS in the years to come. In the meantime, however, it is advisable to remain cautious and the inclusion of patients in clinical trials should be favored.

Expert witness testimony step by step and how to prepare it.

The medical expert witness testimony is a key moment in the pathway of patient complaints as well as in the line of defense of the defendant-physician. For the defendant, it is a difficult time, often experienced as humiliating, because his or her competences are questioned, appraised and discussed in public. However, the defendant must perceive and use this encounter as an opportunity to express his/her viewpoint on the medical accident. This article provides the principal juridical rules that govern the medical expert witness testimony that must be known, as well as some practical advice on how the medical expert witness testimony evolves and how to protect oneself from the complaints, In order to enable the defendant to best prepare for this confrontation between the involved parties.

Medical expert witness testimony in France and in Europe.

Health care professionals are usually at a loss when it comes to medical "complaints", essentially because they lack knowledge with regard to existing litigation procedures. After a short reminder of the different rights of appeal in France, we describe how medical appeals function in other European countries. Next, we give the details of how the evaluation of claims of bodily damage works, a process in which every physician may be called upon to participate several times in a career, either as the defendant, or as a medical counselor, or as an expert. The goal of this update is to understand the different compensation appeal circuits available to patients and help the surgeon demystify and dedramatize the situation while preparing for the medical expert witness testimony. All such testimony reports, via whatever appeal circuit, follow a similar procedure, even if they are not exactly identical.

[CO2 LASER for the treatment of vaginal symptoms of genitourinary syndrome of menopause]. / Place du LASER au CO2 pour le traitement des symptômes vaginaux du syndrome génito-urinaire de la ménopause.

Genitourinary syndrome of menopause (GSM) brings together a collection of signs including vaginal dryness, burning sensation and itching discomfort as well as deterioration of sexual health, dysuria, urgenturia and repeated urinary infections and may be responsible for a significant impairment of quality of life in symptomatic postmenopausal women. The management of GSM therefore represents a public health issue. Systemic or local hormonal treatments are frequently offered, as well as non-hormonal treatments. The existence of contraindications to hormonal treatments and the constraints of using local treatments lead us to propose other therapeutic options. CO2 LASER is now part of the therapeutic arsenal for the treatment of vaginal dryness in the context of GSM. There is a growing interest in this technique, especially for women who have a contraindication to hormonal therapy, as it is a globally effective, long-acting alternative with very little adverse effect. Current evidence suggests that this tool could provide a quality of life benefit to many patients with minimal side effect exposure, if used in the respect of its indications and implementation protocols. However, clinical data based on high-level therapeutic trials remain absolutely essential for this treatment to be validated and recommended by health professionals.

Treatment of polycystic liver disease. Update on the management.

Polycystic liver disease (PLD) may consist of autosomal dominant PLD or isolated PLD without renal impairment. The natural history of liver cysts is to increase in size and number, causing progressive disease that can lead to very large and incapacitating hepatomegaly. Only symptomatic hepatomegaly (pain, inability to eat, weight loss, dyspnea) or cystic complications such as infection or intracystic hemorrhage should be treated. The treatment of PLD thus covers a wide range of therapeutic options, ranging from non-intervention to liver transplantation, including needle aspiration evacuation with injection of sclerosant, laparoscopic fenestration and fenestration by laparotomy combined with liver resection. The choice between these different treatments depends on the symptomatology, the intrahepatic extension of the lesions and the patient's general condition. Hepatic resection is commonly chosen since the vast majority of PLD consists of multiple small cysts that are impossible or difficult to fenestrate. Since cysts are inhomogeneously distributed in the hepatic parenchyma with most areas less affected, the preservation of this less-involved territory allows liver regeneration relatively free of cysts. Hepatectomies for PLD are technically difficult because the planes and the vascular and biliary structures are compressed by the cysts. Liver transplantation, whether isolated or associated with renal transplantation, is indicated in cases of severe malnutrition and/or end-stage renal disease or if the volume of remnant parenchyma is insufficient and suggests failure of a partial hepatectomy.