Closed-loop gastric electrical stimulation versus laparoscopic adjustable gastric band for the treatment of obesity: a randomized 12-month multicenter study.

OBJECTIVE: To compare the weight loss, change in quality of life (QOL) and safety of closed-loop gastric electrical stimulation (CLGES) versus adjustable gastric band (LAGB) in the treatment of obesity. METHODS: This multicenter, randomized, non-inferiority trial randomly assigned the patients in a 2:1 ratio to laparoscopic CLGES versus LAGB and followed them for 1 year. We enrolled 210 patients, of whom 50 were withdrawn preoperatively. Among 160 remaining patients (mean age=39±11 years; 75% women; mean body mass index=43±6 kg m-2) 106 received CLGES and 54 received LAGB. The first primary end point was non-inferiority of CLGES versus LAGB, ascertained by the proportion of patients who, at 1 year, fulfilled: (a) a ⩾20% excess weight loss (EWL); (b) no major device- or procedure-related adverse event (AE); and (c) no major, adverse change in QOL. Furthermore, ⩾50% of patients had to reach ⩾25% EWL. The incidence and seriousness of all AE were analyzed and compared using Mann-Whitney's U-test. RESULTS: At 1 year, the proportions of patients who reached all components of the primary study end point were 66.7 and 73.0% for the LAGB and CLGES group, respectively, with a difference of -6.3% and an upper 95% CI of 7.2%, less than the predetermined 10% margin for confirming the non-inferiority of CLGES. The second primary end point was also met, as 61.3% of patients in the CLGES group reached ⩾25% EWL (lower 95% CI=52.0%; P<0.01). QOL improved significantly and similarly in both groups. AE were significantly fewer and less severe in the CLGES than in the LAGB group (P<0.001). CONCLUSIONS AND RELEVANCE: This randomized study confirmed the non-inferiority of CLGES compared with LAGB based on the predetermined composite end point. CLGES was associated with significantly fewer major AE.

[Results of Surgical and Conservative Treatment for Enterocutaneous Fistulas. Is there an Indication for Conservative Treatment?]. / Therapieergebnisse von Operation und konservativer Therapie enterokutaner Fisteln. Gibt es eine Indikation zur konservativen Behandlung?

INTRODUCTION: The manifestation of enterocutaneous fistulas is varied. They can range from controlled secretion via the abdominal wall to septic disease. The disease is categorised into low-, moderate- and high-output fistulas. Often the only option is surgical treatment. Occasionally, there is spontaneous healing under conservative treatment. The aim of this study was to work out a possible subgroup of patients who benefit from conservative treatment. Material und Methods: Ninety-nine patients were treated for enterocutaneous fistulas from 1 January 1995 to 31 December 2005. Seventy patients underwent surgery, 29 patients were treated conservatively. All data was collected prospectively using an admission form and was analysed retrospectively. Conservative treatment consisted of fasting with parenteral nutrition, while fistulas in the surgical group were treated by suture repair or resection. Additive treatments such as vacuum dressings or TNF-α medication for patients with Crohn's disease were not performed. RESULTS: In our study we achieved a total cure rate of 69%, with an average hospital stay of 38 days. Surgical treatment led to significantly better results compared with conservative treatment (83 vs. 34%). Mortality in the surgical group was distinctly, but not significantly reduced at 7%, compared with 14% in the conservative group. The fistulas that healed after conservative treatment were low-output fistulas only. CONCLUSION: Enterocutaneous fistulas are diseases associated with long hospital stays and, therefore, expensive treatment. Low-output fistulas may heal spontaneously. The best results are achieved by surgical treatment. More recent treatments such as vacuum therapy and TNF-α medication for patients with Crohn's disease are promising approaches. In the future, many of these will have to be combined with surgical treatment.

abiliti Closed-Loop Gastric Electrical Stimulation System for Treatment of Obesity: Clinical Results with a 27-Month Follow-Up.

BACKGROUND: The aim of the study was to evaluate the safety and effectiveness of a novel closed-loop gastric electric stimulation device (abiliti system) featuring a transgastric sensor to detect food intake and an accelerometer to record physical activity to induce and maintain lifestyle changes to treat obesity. METHODS: In a prospective, multi-center study, 34 obese subjects (BMI of 42.1 ± 5.3 kg/m(2)) who passed an eligibility evaluation were implanted with the abiliti system. Safety evaluation included an endoscopic exam to assess the intragastric electrode healing. Efficacy evaluation at 1 year of therapy included weight loss, improvements in eating, and exercise behavior and quality of life. RESULTS: The transgastric implant controlled by endoscopy was stable for all participants. At 12 months (12 M) the mean excess weight loss (EWL) was 28.7% (95%CI, 34.5 to 22.5%), and mean reduction in BMI was 4.8 ± 3.2 kg/m(2). At 27 months (27 M), the EWL was 27.5% (95% CI, 21.3% to 33.7%). Eating behavior, evaluated by the "Three Factor Eating Questionnaire", showed a significant increase in the cognition factor and decrease in the disinhibition and hunger factors at 12 M in comparison to baseline (p < 0.001). Participants significantly increased their weekly physical activity (p < 0.001). Quality of life was improved in 55.2% of the patients. CONCLUSIONS: Gastric electrical stimulation with abiliti system in obese participants is well tolerated and leads to significant 12 M weight loss, which was stable to 27 M. We suggest that weight loss is achieved due to the assessed alteration of eating behavior in particular the reduction in disinhibition and hunger, and the measured increase in physical activity.

[Results of surgical treatment of hiatal hernia]. / Ergebnisse der operativen Therapie großer Hiatushernien.

BACKGROUND: Hiatus hernias are considered as the most prominent form of diaphragmatic hernias. The passage is defined through the oesophageal hiatus, resulting in a superdiaphragmatic displacement of parts of the stomach or the complete stomach, respectively. In our work we investigated the treatment of partial thoracic stomach with both open and minimally invasive surgical procedures emphasising the view on operating data, the success of the surgery and recurrence rates. Patients with mesh insertion for hernia defect closures were considered separately. MATERIAL AND METHOD: 94 Patients were treated in the period from 01.01.2003 to 01.06.2010. The ratio male/female was 2 : 1. The median age was 66 years. All data were prospectively collected by means of surgical protocols and data from the central patient records and analysed retrospectively. The statistical analyses were performed with SPSS 18.0 (SPSS Inc., Chicago, IL, USA). Any existing significances were determined using the T-test. RESULTS: Of the 94 patients, 65 were operated laparoscopically. In the case of nine patients an initial laparoscopic surgery had to be changed to an open procedure. The reasons for switching surgical procedures were splenic bleeding in the case of 2 patients, intestinal injury due to perforation by the trocar in one case and unclear surgical situs in 6 cases. The postoperative complication rate was 24 %. The main reasons were a delayed achievement of passage. The mortality rate was 0 %. The comparison between laparoscopic and open groups showed, by comparable complication and recurrence rates, a shorter recovery time in favour of patients operated on laparoscopically. Additionally it can be stated that a bridge closure with mesh (ePTFE) had no significant influence on the postoperative outcome. Therefore we cannot confirm the postulated poor postoperative results of other groups. CONCLUSION: In summary, the clear trend in the surgical treatment of hiatus hernias is to minimally invasive surgery. Only for patients with multiple previous operations, who are expected to have strong adhesions, the operation with comparable morbidity and mortality rates can also be planned primarily as open. In this case, however, longer postoperative recovery times must be expected. Large defects can be treated with comparable complication and recurrence rates by mesh insertion (ePTFE).

[The role of oxidative damage of proteins and lipids in pathogenesis of traumatic disease in severe combined thoracic trauma].

The investigation objective was to study the dynamics of indices of the lipids and proteins oxidative damage, as well as search for possible prognostic criteria in the injured persons with severe combined thoracic trauma. Concentration of carbonyl groups of proteins and malonic dialdehyde was determined on 1-2d, 3-4th and 5-6th day after trauma in the blood plasm of 73 patients, ageing 20 -68 yrs old. While in conditions of massive infusion therapy concentration of the indices investigated do not reflect the oxidative processes intensity. Relative concentration in recalculation on concentration of common protein content constitutes a more demonstratable index. On the 5-6th day after trauma a tendency for normalization of the oxidative damage of lipids and proteins indices was observed in the patients, who have recovered, and while lethal outcome--their further enhancement was noted. There was established a one-direction dynamics of a relative indices in both groups up to 3-4-th day after trauma with a step-by-step its enhancement. Concentration of carbonyl groups of proteins more than 15.86 mcmol/g of protein on the 5-6-th day after trauma ought to be considered a trustworthy criterion of unfavorable prognosis.

[New data on quality assurance in bariatric surgery in Germany]. / Aktuelle Daten der Qualitätssicherungsstudie für operative Therapie der Adipositas in Deutschland.

BACKGROUND: Since January 1st 2005, the situation of bariatric surgery has been examined in Germany. All data are registered prospectively in cooperation with the Institute of Quality Assurance in Surgery at the Otto-von-Guericke University of Magdeburg. METHODS: The voluntary data registration occurs in an internet online data bank. All primary bariatric procedures as well as re- and redo-procedures are documented. Follow-up data were collected once a year. Participation in the quality assurance study is obligatory for certificated centres. RESULTS: Since 2005 13,879 bariatric procedures have been performed at 83 hospitals. The number of primary procedures has increased from 596 in 2005 to 11,835 in 2010. Revisional surgery has been performed in 1,438 patients since 2005. Sleeve gastrectomy (SG) is the major procedure with 1,564 operations in 2010. The mean BMI was 48.8 kg/m². The incidence of comorbidities was 84.8%. CONCLUSION: Bariatric surgery has become more accepted in Germany. Beside the Roux-en-Y gastric bypass, sleeve gastrectomy is the most frequently performed operation. BMI and incidence of comorbidities are still high in comparison with literature values. Due to the lack of evidence, more randomised studies are necessary to standardise operative techniques and evaluate patient selection criteria. Quality assurance studies support a detailed analysis of these parameters.

Actual situation of thromboembolic prophylaxis in obesity surgery: data of quality assurance in bariatric surgery in Germany.

Background. Evidence-based data on optimal approach for prophylaxis of deep venous thrombosis (VTE) and pulmonary embolism (PE) in bariatric operations is discussed. Using antithrombotic prophylaxis weight adjusted the risk of VTE and its complications have to be balanced with the increased bleeding risk. Methods. Since 2005 the current situation for bariatric surgery has been examined by quality assurance study in Germany. As a prospective multicenter observational study, data on the type, regimen, and time course of VTE prophylaxis were documented. The incidences of clinically diagnosed VTE or PE were derived during the in-hospital course and follow up. Results. Overall, 11,835 bariatric procedures were performed between January 2005 and December 2010. Most performed procedures were 2730 gastric banding (GB); 4901 Roux-en-Y-gastric bypass (RYGBP) procedures, and 3026 sleeve gastrectomies (SG). Study collective includes 72.5% (mean BMI 48.1 kg/m(2)) female and 27.5% (mean BMI 50.5 kg/m(2)) male patients. Incidence of VTE was 0.06% and of PE 0.08%. Conclusion. VTE prophylaxis regimen depends on BMI and the type of procedure. Despite the low incidence of VTE and PE there is a lack of evidence. Therefore, prospective randomized studies are necessary to determine the optimal VTE prophylaxis for bariatric surgical patients.

[Bariatric surgery in a patient with adipositas permagna and uncontrolled insulin resistance]. / Bariatrischer Eingriff bei einem Patienten mit Adipositas permagna und nicht beherrschbarer Insulinresistenz.

HISTORY AND ADMISSION FINDINGS: A 58-year-old patient had a 21 years history of diabetes mellitus and multiple diabetic complications. In addition he suffered from severe obesity with a body mass index of 42.7 kg/m² and a waist circumference of 141 cm. After all treatment options according to the national guidelines had failed the patient was admitted to a diabetes clinic. INVESTIGATIONS: All approaches on the metabolic ward to control insulin resistance failed as well and finally blood glucose levels could only be stabilized with the aid of continous subcutaneous insulin infusion with more than 500 units per day. The patient's quality of life and the options for physical activity were extremely limited. TREATMENT AND COURSE: Thus, the indication of bariatric surgery was discussed with the interdisciplinary team of specialists and with the patient. After informed consent a Roux-Y gastric bypass was established with the aid of minimal invasive surgery. Already two weeks after the operation insulin demand had decreased to 100 units per day and metabolic control and the treatment could be further optimized. Three months later the body mass index was reduced to 34.3 kg/m². The treatment improved the patient's quality of life, optimized metabolic control and resulted last but not least in lower costs for the diabetes treatment. CONCLUSION: Bariatric surgery is an additional option in the treatment of obesity and insulin resistance. The collaboration between diabetologists and bariatric surgeons is a prerequisite for the successful selection of patients and for longterm control after surgery.