Taurolidine reduces the tumor stimulating cytokine interleukin-1beta in patients with resectable gastrointestinal cancer: a multicentre prospective randomized trial

Background The effect of additional treatment strategies with antineoplastic agents on intraperitoneal tumor stimulating interleukin levels are unclear. Taurolidine and Povidone-iodine have been mainly used for abdominal lavage in Germany and Europe. Methods In the settings of a multicentre (three University Hospitals) prospective randomized controlled trial 120 patients were randomly allocated to receive either 0.5% taurolidine/2,500 IU heparin (TRD) or 0.25% povidone-iodine (control) intraperitoneally for resectable colorectal, gastric or pancreatic cancers. Due to the fact that IL-1beta (produced by macrophages) is preoperatively indifferent in various gastrointestinal cancer types our major outcome criterion was the perioperative (overall) level of IL-1beta in peritoneal fluid. Results Cytokine values were significantly lower after TRD lavage for IL-1beta, IL-6, and IL-10. Perioperative complications did not differ. The median follow-up was 50.0 months. The overall mortality rate (28 vs. 25, p = 0.36), the cancer-related death rate (17 vs. 19, p = .2), the local recurrence rate (7 vs. 12, p = .16), the distant metastasis rate (13 vs. 18, p = 0.2) as well as the time to relapse were not statistically significant different. Conclusion Reduced cytokine levels might explain a short term antitumorigenic intraperitoneal effect of TRD. But, this study analyzed different types of cancer. Therefore, we set up a multicentre randomized trial in patients undergoing curative colorectal cancer resection. Trial registration : ISRCTN6647853

Challenges and pitfalls of experimental bariatric procedures in rats

Introduction: The impact of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) on obesity and obesity-related diseases is unquestionable. Up to now, the technical descriptions of these techniques in animals/rats have not been very comprehensive. Methods: For SG and RYGB, operating time, learning curve, and intraoperative mortality in relation to weight of the rat and type of anesthesia were recorded. Furthermore, a review of the literature on experimental approaches towards SG and RYGB in rats was carried out, merging in a detailed technical description for both procedures. Results: The data presented here revealed that the mean operating time for SG (69.4 +/- 22.2 min (SD)) was shorter than for RYGB (123.0 +/- 20.7 min). There is a learning curve for both procedures, resulting in a reduced operating time of up to 60% in SG and 35% in RYGB (p < 0.05; t-test). However, with increased weight, operating time increases to about 80 min for SG and about 120 min for RYGB. Obese rats have an increased intraoperative mortality rate of up to 50%. After gaseous anesthesia the mortality can be even higher. The literature search revealed 40 papers dealing with SG and RYGB in rats. 18 articles (45%) contained neither photographs nor illustrations; 14 articles (35%) did not mention the applied type of anesthesia. The mortality rate was described in 15 papers (37.5%). Conclusion: Experimental obesity surgery in rats is challenging. Because of the high mortality in obese rats operated under gaseous anesthesia, exercises to establish the techniques should be performed in small rats using intraperitoneal anesthesia. Copyright (C) 2012 S. Karger GmbH, Freibur

LigaSure Impact™ versus conventional dissection technique in pylorus-preserving pancreatoduodenectomy in clinical suspicion of cancerous tumours on the head of the pancreas: study protocol for a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>The pp-Whipple procedure requires extensive preparation. The conventional preparation technique is done with scissors for dissection and ligatures, and with clips and sutures for hemostasis. This procedure is very time-consuming and requires numerous changes of instruments. The LigaSure™ device allows dissection and hemostasis for preparation with one instrument. Up to now there has been no comparison of the two techniques with regard to operating time and the patients' outcome. It is still unclear which technique has the optimal benefit/risk ratio for the patient.</p> <p>Methods/Design</p> <p>A single-center, randomized, single-blinded, controlled superiority trial to compare two different techniques for dissection in a pp-Whipple procedure. 102 patients will be included and randomized pre-operatively. All patients aged 18 years or older scheduled for primary elective pp-Whipple procedure who signed the informed consent will be included. The primary endpoint is the operating time of the randomized technique. Control Intervention: Conventional dissection technique; experimental intervention: LigaSureTM dissection technique. Duration of study: Approximately 15 months; follow up time: 3 years. The trial is registered at German ClinicalTrials Register (DRKS00000166).</p

Анализ эффективности эксплуатации системы регенерации высокого давления на Ростовской атомной станции

Объектом исследования является система регенерации высокого давления энергоблока АЭС с реактором ВВЭР-1000. Цель работы – проанализировать эффективность работы системы регенерации высокого давления Ростовской АЭС. В процессе расчетов проведен тепло-гидравлический и конструкторский расчеты подогревателя высокого давления. В результате расчета определены оптимальные геометрические размеры поверхности теплообмена подогревателя. Основные конструктивные, технологические и технико-эксплуатационные характеристики: теплоноситель - влажный пар с давлением 2.785 МПа и степенью сухости 0.919, рабочее тело - питательная во-да с давлением 8.922 МПа, температурой на входе 200.4 на выходе 225 .The object of research is the system of high-pressure regeneration NPP with VVER-1000 reactor. Objective - To analyze the efficiency of regeneration system of Rostov NPP high pressure. In the process of calculation performed heat-hydraulic calculations and design of high pressure heater. As a result of calculating the optimal geometric dimensions heater heat exchange surface. The basic constructive, technological and technical and operational characteristics: coolant - wet steam with pressures-tion 2.785 MPa and the degree of dryness of 0.919, working body - the food first, but with the pressure of 8,922 MPa, inlet temperature of 200.4 at the output 225

Laparoscopic mesh-augmented hiatoplasty without fundoplication as a method to treat large hiatal hernias

PURPOSE: Laparoscopic hiatal hernia repair with additional fundoplication is a commonly recommended standard surgical treatment for symptomatic large hiatal hernias with paraesophageal involvement (PEH). However, due to the risk of persistent side effects, this method remains controversial. Laparoscopic mesh-augmented hiatoplasty without fundoplication (LMAH), which combines hiatal repair and mesh reinforcement, might therefore be an alternative. METHODS: In this retrospective study of 55 (25 male, 30 female) consecutive PEH patients, the perioperative course and symptomatic outcomes were analyzed after a mean follow-up of 72 months. RESULTS: The mean DeMeester symptom score decreased from 5.1 to 1.8 (P < 0.001) and the gas bloating value decreased from 1.2 to 0.5 (P = 0.001). The dysphagia value was 0.7 before surgery and 0.6 (P = 0.379) after surgery. The majority of the patients were able to belch and vomit (96 and 92 %, respectively). Acid-suppressive therapy on a regular basis was discontinued in 68 % of patients. In 4 % of patients, reoperation was necessary due to recurrent or persistent reflux. A mesh-related stenosis that required endoscopic dilatation occurred in 2 % of patients. CONCLUSIONS: LMAH is feasible, safe and provides an anti-reflux effect, even without fundoplication. As operation-related side effects seem to be rare, LMAH is a potential treatment option for large hiatal hernias with paraesophageal involvement

Totally laparoscopic versus conventional ileoanal pouch procedure – design of a single-centre, expertise based randomised controlled trial to compare the laparoscopic and conventional surgical approach in patients undergoing primary elective restorative proctocolectomy- LapConPouch-Trial

BACKGROUND: Restorative proctocolectomy is increasingly being performed minimal invasively but a totally laparoscopic technique has not yet been compared to the standard open technique in a randomized study. METHODS/DESIGN: This is a two armed, single centre, expertise based, preoperatively randomized, patient blinded study. It is designed as a two-group parallel superiority study. Power calculation revealed 80 patients per group in order to recruit the 65 patients to be analysed for the primary endpoint. The primary objective is to investigate intra-operative blood loss and the need for blood transfusions. We hypothesise that intra-operative blood loss and the need for peri-operative blood transfusions are significantly higher in the conventional group. Additionally a set of surgical and non-surgical parameters related to the operation will be analysed as secondary objectives. These will include operative time, complications, postoperative pain, lung function, postoperative length of hospital stay, a cosmetic score and pre-and postoperative quality of life. DISCUSSION: The trial will answer the question whether there is indeed an advantage in the laparoscopic group in regard to blood loss and the need for blood transfusions. Moreover, it will generate data on the safety and potential advantages and disadvantages of the minimally invasive approach

Acute cholecystitis – early laparoskopic surgery versus antibiotic therapy and delayed elective cholecystectomy: ACDC-study

<p>Abstract</p> <p>Background</p> <p>Acute cholecystitis occurs frequently in the elderly and in patients with gall stones. Most cases of severe or recurrent cholecystitis eventually require surgery, usually laparoscopic cholecystectomy in the Western World. It is unclear whether an initial, conservative approach with antibiotic and symptomatic therapy followed by delayed elective surgery would result in better morbidity and outcome than immediate surgery. At present, treatment is generally determined by whether the patient first sees a surgeon or a gastroenterologist. We wish to investigate whether both approaches are equivalent. The primary endpoint is the morbidity until day 75 after inclusion into the study.</p> <p>Design</p> <p>A multicenter, prospective, randomized non-blinded study to compare treatment outcome, complications and 75-day morbidity in patients with acute cholecystitis randomized to laparoscopic cholecystectomy within 24 hours of symptom onset or antibiotic treatment with moxifloxacin and subsequent elective cholecystectomy. For consistency in both arms moxifloxacin, a fluorquinolone with broad spectrum of activity and high bile concentration is used as antibiotic. Duration: October 2006 – November 2008</p> <p>Organisation/Responsibility</p> <p>The trial was planned and is being conducted and analysed by the Departments of Gastroenterology and General Surgery at the University Hospital of Heidelberg according to the ethical, regulatory and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and the Good Clinical Practice guideline (GCP).</p> <p>Trial Registration</p> <p>ClinicalTrials.gov NCT00447304</p

Reversible biliary occlusion in a small animal model: first description of a new technique

Experimental models with reversible biliary occlusion resulted in a high mortality of the animals, up to 20–60% according to the literature. Our aim was to assess a safe and valid technique for reversible biliary occlusion with a low mortality