Medico-legal claims in bariatric surgery in France between 2010 and 2015.

PURPOSE OF THE STUDY: The practice of bariatric surgery has multiplied 3.5 times in France in the last ten years. The purpose of the study is to analyze medico-legal claims in this area in order to identify lessons to improve patient care. PATIENTS AND METHODS: Two visceral surgeons analyzed 358 independent claim files. Age, gender, socio-economic origin, body mass index, surgical history, depression, smoking, anticoagulants, and pre-operative assessment of patients were recorded. The operative indication, the type and date of occurrence of the event, the existence and causes of intra-operative incidents, re-interventions, inter-hospital transfers and deaths were noted. Any anomaly of care, whether noted by the expert or the court, was considered a fault. RESULTS: The types of bariatric procedures included sleeve gastrectomy in 52.1% of cases and gastric bypass in 33.2% of cases. A third of patients (31.2%) had a history of previous abdominal surgery. The main complications were anastomotic leak (48.6%), followed by vomiting, wounds of neighboring organs, and infections. Fault was found in 30.4% of cases: for delay of care (36.8%), surgical clumsiness or ineptitude (15.5%), incorrect indications, lack of patient information. In 6.4% of cases, metabolic deficiencies with encephalopathy developed. CONCLUSION: The indications of the French High Authority of Health [Haute autorité de santé (HAS)] must be respected and intra-operative difficulties should not be underestimated in patients who have undergone previous surgery. Post-operatively, clinical signs of severity take precedence over complementary examinations, even when negative. Close monitoring is necessary to quickly detect complications that occur outside the facility, whether it is a surgical complication or vitamin deficiency.

Malpractice claims and abdominal wall hernia repair.

PURPOSE: To present factual data on the medico-legal aspects of medicolegal claims after abdominal wall surgery in France. METHOD: Analysis of the complaints following parietal surgery that were addressed to a company that specializes in medical malpractice insurance between 2010 and 2016. RESULTS: Of 209 files, 180 were analyzable; these included 75 women and 105 men with a mean age of 51 years and a mean BMI of 29.8. Cases were mainly heard by the Conciliation and Compensation Commission (CCI) (82 patients) and the High Court (79 patients). The surgical procedures concerned were groin hernias (85 patients) or anterior abdominal wall hernias (95 patients). Conventional open surgery was performed in 123 patients and laparoscopic surgery in 57 patients. The incidents motivating patient complaints after groin hernia surgery were chronic pain (27 patients), infection (24 patients), testicular damage (10 patients). Seven patients died as a result of this surgery (including one fetus). Claims after ventral hernia repair were motivated by infections (46 patients) and post-operative peritonitis or bowel obstruction (12 patients). Nine patients died following these ventral hernia repairs. Surgical error was identified in 59 of the 168 cases analyzed (35.1%); 44% of recognized faults were surgical site infections, 27% linked to delay in re-operation, and 20% were related to the operating room environment. CONCLUSION: Hernia surgery, although an everyday event for many practitioners, requires the same rigor as all other visceral surgery.

Risk management for surgical energy-driven devices used in the operating room.

Complications related to energy sources in the operating room are not well-recognized or published, despite occasionally dramatic consequences for the patient and the responsible surgeon. The goal of this study was to evaluate the risks and consequences related to use of energy sources in the operating room. PATIENTS AND METHODS: Between 2009 and 2015, 876 adverse events related to health care (AERHC) linked to energy sources in the operating room were declared in the French experience feedback data base "REX". We performed a descriptive analysis of these AERHC and analyzed the root causes of these events and of the indications for non-elective repeat operations, for each energy source. RESULTS: Five different energy sources were used, producing 876 declared AERHC: monopolar electrocoagulation: 614 (70%) AERHC, advanced bipolar coagulation (thermofusion): 137 (16%) AERHC, ultrasonic devices: 69 (8%) AERHC, traditional bipolar electrocoagulation: 32 AERHC, and cold light: 24 AERHC. The adverse events reported were skin burns (27.5% of AERHC), insulation defects (16% of AERHC), visceral burns or perforation (30% of AERHC), fires (11% of AERHC), bleeding (7.5% of AERHC) and misuse or miscellaneous causes (8% of AERHC). For the five energy sources, the root causes were essentially misuse, imperfect training and/or cost-related reasons regarding equipment purchase or maintenance. One hundred and forty-six non-elective procedures (17% of AERHC) were performed for complications related to the use of energy sources in the operating room. CONCLUSION: This study illustrates the risks related to the use of energy sources on the OR and their consequences. Most cases were related to persistent misunderstanding of appropriate usage within the medical and paramedical teams, but complications are also related to administrative decisions concerning the purchase and maintenance of these devices.

Risk factors of perioperative morbimortality after laparoscopic sleeve gastrectomy: a club coelio multicenter study.

OBJECTIVES: Postoperative complications after Laparoscopic sleeve gastrectomy (LSG) can dramatically compromise patient's outcome. The aim of this study is to analyze the per- and postoperative short-term outcomes after LSG and to assess predictive risk factors of complications. METHODS: The study group consisted of 790 patients (610 women and 180 men) who underwent LSG In 2014. All interventions were performed by 18 experienced surgeons members of the Club Coelio. Data about preoperative work-up, surgical techniques, 30-days postoperative morbidity and mortality were collected. Endpoints were perioperative morbidity and mortality and assessment of potential risk factors for complications. RESULTS: Mean age and body mass index were respectively 39 years and 41.5kg/m2. Ninety-one patients (11.5%) had previous bariatric surgery. Morbidity rate was 4.7% (37/790) including 16 leaks (2.0%) and 9 bleedings (1.1%) and no deaths. Risk factors for leak were: previous adjustable banding (p = .0051), with no difference between removal of the banding and LSG in 1 or 2 steps, and type of endostapler (p = .0129). CONCLUSIONS: Leakage after Sleeve was rare but still observed even in experienced hands. The leak rate is particularly high when LSG is performed after adjustable gastric banding removal.

Previous bariatric surgery increases postoperative morbidity after sleeve gastrectomy for morbid obesity.

OBJECTIVES: Sleeve gastrectomy (SG) has been used as the first step of a staged malabsorptive procedure for high-risk patients. More recently SG was proposed as an stand alone procedure in the treatment of morbidly obese patients. The aim of this study is to analyze perioperative outcome of morbid obese patients after SG. METHODS: 301 patients, 201 women and 100 men, undergoing SG were retrospectively analyzed. SG was performed by 17 surgeons all member of the Club Coelio. The mean BMI was 44.7kg/m2 (27.4-70.3 kg/m2). 34 patients (11.3%) of our series had SG as revisional surgery. These revisional procedures consisted of 32 conversions from gastric banding, 1 conversion from vertical gastroplasty (VBG) and 1 from transoral endoscopic gastroplasty. Among the 32 patients that had revisional SG after a gastric banding, 13 bands were removed at least 3 months before the revisional SG and 19 bands were removed during the SG procedure. Endpoints were perioperative morbidity and mortality and potential risk factors for complications, mainly per or postoperative bleeding or leakage. RESULTS: Overall mortality was 0% and morbidity was 10.3%. Perioperative bleeding occurred in 10 patients (3.3%), leakage in 12 patients (4%) patients and stenosis in 3 patients (1%). The risk of leakage was significantly higher after revisional bariatric surgery and in case of gastric perforation during surgery (p = 0.0001). Previous gastric banding is also associated with a higher risk of postoperative bleeding (p = 0.0006). CONCLUSIONS: SG can be safely performed but patients and surgeons must be aware of a higher risk of postoperative complications when SG is proposed as a revisional surgery.

Mesh infection after inguinal hernia mesh repair.

INTRODUCTION: Infection after repair of groin hernia is rare, even since the advent of mesh repair. The debate remains open about antibiotic prophylaxis. AIM OF THE STUDY: Assess incidence of this kind of complication, determine criteria of diagnosis and strategy of therapy by examining the collective experience of 32 surgeons. METHOD: Fifty surgeons were asked to report their experience with mesh repair of inguinal hernias and specifically mesh infection. Diagnosis and therapy for each mesh infection were detailed. RESULTS: Forty-five cases were reported in 38 patients who had undergone open or laparoscopic mesh repair. Diagnosis was straightforward and established at a variable delay after mesh insertion: 51% during the first postoperative month; 26% more than one year after the procedure. Infection cured in 33 patients after mesh removal, in one step in 14 cases, but after many attempts for conservative therapy in 19 cases; the mean delay to cure was 12.5 months. Visceral resections had to be associated with mesh removal in 13% of cases. CONCLUSIONS: This is the largest series of mesh infections after inguinal hernia repair reported in the literature. According to the evidence provided here, mesh removal appears to be the most appropriate treatment of this rare and serious complication.

Intraoperative events and their outcome: data from 4007 laparoscopic interventions by the French "Club Cœlio".

AIM: To assess the operative and postoperative course of intraoperative events occurring in laparoscopic surgery according to the classification of Clavien. This evaluation aims at ascertaining morbidity and mortality of abdominal laparoscopic operations, thus serving as a reference for future comparative studies. METHOD: Twenty-nine senior surgeons, all of them members of the Cœlio Club prospectively and consecutively summarized all their laparoscopic activity over a period of 6 months. RESULTS: Of 4007 patients, 373 (9.31%) developed complications, 69 (1.72%) requiring surgery. Establishing the pneumoperitoneum and trocar placement caused 15 vascular (0.37%) and six visceral (0.15%) injuries; seven vascular (0.17%) and 22 visceral (0.55%) injuries occurred intraoperatively. Surgery of the colon and especially the rectum were associated with the highest morbidity with Clavien grades III, IV and V reported in 8, 10 and 15.97% of patients, respectively; 1.2% occurred in biliary surgery and 0.67% in inguinal/femoral hernia repair. CONCLUSION: The prevalence of surgical intraoperative events and postoperative complications is higher than reported in the literature. Clavien's classification is applicable to abdominal laparoscopic surgery; further information is necessary to assess intraoperative surgical events as well as conversions.

[Inguinal hernia. What are the criteria for assessing the result of hernia repair?]. / Hernie de l'aine: sur quels critères faut-il juger du résultat de la cure de hernie?

The assessment criteria reflect the questions patients ask at the preoperative visit: Is it painful? How long will the operation last? How long will I be hospitalized? How long until I can resume daily activities? What is the risk of recurrence? Is there a risk of long-term disability? Inguinal hernia repair is of one of the most widely assessed surgical procedures, even for more recent procedures: three Cochrane databases, eight meta-analyses and nearly 100 prospective randomized trials cover this topic. Many facts are now established: There are significantly more recurrences after suture than after mesh techniques; for mesh, there is no difference between laparoscopic and conventional approaches.

Laparoscopic cure of small ventral hernias with composite mesh.

BACKGROUND: The use of mesh is recommended to reduce the rate of recurrence after the curing of ventral hernias. METHODS: A multicentre prospective trial was conducted to assess the laparoscopic cure of small ventral hernias with a composite mesh. RESULTS: Around 222 patients entered the trial and received laparoscopic repair for ventral hernias of less than 5 cm. There was one conversion. The mean length of post-operative hospitalisation was 2.5 days. At 1 year, the recurrence rate was 2%. Two meshes were removed due to infection, 3% of the patients were using analgesics and 86.1% of the patients described no pain on EVA scoring. CONCLUSION: The laparoscopic cure of small ventral hernias with composite mesh is efficient. Further technical progress is warranted to reduce the rate of seroma formation.

[Risk knowledge and management of blood exposure in operative room: results of a French national survey]. / Connaissance du risque et attitude en cas d'exposition au sang au bloc opératoire : résultats d'une enquête nationale.

OBJECTIVES: To assess knowledge of risk factors of blood exposure in operative room and management after blood exposure. METHODS: A national survey was conducted towards 5000 surgeons drawn with hazard. RESULTS: The knowledge of the risk of viral contamination stay imperfect and the management after blood exposure is doubtful, and this last point is probably favoured by the absence of regulation in spite of guidelines from professional associations or societies. CONCLUSION: Knowledge of risk factors and more clear regulations could permit a better attitude in case of blood exposure.

[Incidence of surgical site infection in ambulatory surgery: results of the INCISCO surveillance network in 1999-2000]. / Incidence des infections du site opératoire en chirurgie ambulatoire: résultats du réseau de surveillance INCISO en 1999-2000.

OBJECTIVES: To estimate the incidence of surgical-site infections (SSI) in ambulatory surgery and to identify risk factors based on the surveillance network INCISO in 1999-2000. PATIENTS AND METHODS: Annually, during a three-month period, each surgical ward had to include 200 consecutive operations. Patients were surveyed over the month following surgery. For each patient, data including peri-operative factors, type of procedure and SSI occurrence were collected on a standardized form by a surgical staff committed for the study. RESULTS: Of the 5,183 patients who underwent an ambulatory surgery, the SSI incidence ratio was 0.4% (95% CI [0.3-0.7]). Orthopedic, gynecologic/obstetrics, head and neck, skin and soft tissues surgery accounted for 83% of all ambulatory procedures. 93% of patients belonged to the 0 risk category of the National Nosocomial Infections Surveillance system (NNIS) index. Emergency, age, american anesthesia risk score (ASA), Altemeier wound class, and procedure duration were not found to be risk factors for SSI in ambulatory surgery. CONCLUSION: Based on these surveillance data, infectious risk was low in ambulatory surgery and was not associated with known SSI risk factors.

[Outpatient laparoscopic cholecystectomy]. / Cholécystectomie par laparoscopie en ambulatoire.

UNLABELLED: OUTPATIENT LAPAROSCOPIC CHOLECYSTECTOMY: The laparoscopic technique is the procedure of choice for cholecystectomy. This procedure is done on ambulatory setting in the United States and Europe but no experience was reported in France. AIM OF THE STUDY: To report the organisation and results of our initial 100 consecutive patients operated for a laparoscopic cholecystectomy on an outpatient basis. PATIENTS AND METHODS: After assessment of the prevention of pain and nausea or vomiting after laparoscopic cholecystectomy on hospitalized patients, a prospective trial was done on our first 100 patients for outpatient laparoscopic cholecystectomy on routine basis. RESULTS: During the period, 27.4% of patients were entered on an ambulatory basis. 72% of patients did not need any medication post-operatively in the structure. 17 patients were admitted: in five cases, decision was done pre-operatively, one patient went back home against medical advising; in three cases, peroperatively, and in 10 cases postoperatively. Four patients were readmitted between the fifth and sixteenth post-operatoire day. CONCLUSION: An adequate organisation for day case surgery, a good selection of patients on medical, surgical and environmental criteria, simple procedures to prevent pain or nausea vomiting post-operatively allow use to assert that hospitalisation is unjustified for laparoscopic cholecystectomy in a quater of patients.

[Blunt force rupture of the thoracic aorta and diaphragm: an unusual association]. / Rupture de l'isthme aortique et de la coupole diaphragmatique droite: une association inhabituelle.

The aim of this study was to report two cases of rupture of the right hemidiaphragm with intra-thoracic liver hernia, associated with a traumatic aortic disruption. These two lesions followed traffic accidents, and were both treated separately. Both patients had a long-term favourable progression. Association of these two lesions is particularly rare: fewer than 50 cases have been previously described in an extensive review of the literature. CT-scan seems to be particularly efficient in diagnosis, even if less efficient than other more specific explorations. The order of surgical management is guided by the physical examination, and especially by abdominal emergency.