Prospective trial to evaluate the prognostic value of different nutritional assessment scores in pancreatic surgery (NURIMAS Pancreas).

BACKGROUND: Preoperative nutritional status has an impact on patients' clinical outcome. For pancreatic surgery, however, it is unclear which nutritional assessment scores adequately assess malnutrition associated with postoperative outcome. METHODS: Patients scheduled for elective pancreatic surgery at the University of Heidelberg were screened for eligibility. Twelve nutritional assessment scores were calculated before operation, and patients were categorized as either at risk or not at risk for malnutrition by each score. The postoperative course was monitored prospectively by assessors blinded to the nutritional status. The primary endpoint was major complications evaluated for each score in a multivariable analysis corrected for known risk factors in pancreatic surgery. RESULTS: Overall, 279 patients were analysed. A major complication occurred in 61 patients (21·9 per cent). The proportion of malnourished patients differed greatly among the scores, from 1·1 per cent (Nutritional Risk Index) to 79·6 per cent (Nutritional Risk Classification). In the multivariable analysis, only raised amylase level in drainage fluid on postoperative day 1 (odds ratio (OR) 4·91, 95 per cent c.i. 1·10 to 21·84; P = 0·037) and age (OR 1·05, 1·02 to 1·09; P = 0·005) were significantly associated with major complications; none of the scores was associated with, or predicted, postoperative complications. CONCLUSION: None of the nutritional assessment scores defined malnutrition relevant to complications after pancreatic surgery and these scores may thus be abandoned.

[Liver transection: modern procedure: Technique, results and costs]. / Lebertranssektion: moderne Verfahren : Technik, Ergebnisse und Kosten.

Liver resection has developed into the current standard procedure due to modern resection techniques, profound knowledge of the liver anatomy and optimized surgical and anesthesiological strategies to allow extended resections with both low morbidity and mortality. Initially major blood loss was the biggest concern with liver resection and a Pringle's manoeuvre was necessary. Nowadays, biliary leakage is the major problem after liver surgery. Besides the classical conventional clamp crushing technique for parenchymal transection, various devices including ultrasound, microwaves and staplers have been introduced. Minimally invasive techniques have become increasingly important for liver resection but are still applied in selected patients only. The selection of the resection technique and device mainly depends on the extent of the resection and also on the liver parenchyma, the liver disease, costs, personal experiences and preferences. This article presents a selection of techniques used in modern parenchymal transection during liver resection with special focus on transection time, blood loss, bile leakage and costs.

[Surgery and the zeitgeist: what happened to ethics and moral?]. / Chirurgie und Zeitgeist: Wo bleiben Ethik und Moral?

Ethical and moral topics have always been an integral part of surgery. The rapid progress of highly advanced medicine has induced public discussions about medico-ethical problems as well as respective legislation. Interdisciplinary ethical committees, appointed by political as well as professional associations, have published guidelines concerning current ethical topics. However, what about the doctor's attitude and the influence of the ever changing "Zeitgeist"? With the surplus of unproven health information on the web, modern information technologies have changed the doctor-patient relationship. Active leadership of the doctor is still required. For the benefit of the patient the physician should confront increasing economic pressures and the requirements of higher performance levels with competence. Indications have to be based on the results of valid quality controls. Special moral standards should be applied for working within the surgical community and for the pursuit of a career in academic surgery. By strengthening mutual respect and the community spirit surgery will remain attractive for aspiring young doctors.

[Challenges in building a surgical obesity center]. / Herausforderungen beim Aufbau eines operativen Adipositaszentrums.

BACKGROUND: It is estimated that approximately 1 million adults in Germany suffer from grade III obesity. The aim of this article is to describe the challenges faced when constructing an operative obesity center. METHODS: The inflow of patients as well as personnel and infrastructure of the interdisciplinary Diabetes and Obesity Center in Heidelberg were analyzed. The distribution of continuous data was described by mean values and standard deviation and analyzed using variance analysis. RESULTS: The interdisciplinary Diabetes and Obesity Center in Heidelberg was founded in 2006 and offers conservative therapeutic treatment and all currently available operative procedures. For every operative intervention carried out an average of 1.7 expert reports and 0.3 counter expertises were necessary. The time period from the initial presentation of patients in the department of surgery to an operation was on average 12.8 months (standard deviation SD ± 4.5 months). The 47 patients for whom remuneration for treatment was initially refused had an average body mass index (BMI) of 49.2 kg/m(2) and of these 39 had at least the necessity for treatment of a comorbidity. Of the 45 patients for whom the reason for the refusal of treatment costs was given as a lack of conservative treatment, 30 had undertaken a medically supervised attempt at losing weight over at least 6 months. Additionally, 19 of these patients could document participation in a course at a rehabilitation center, a Xenical® or Reduktil® therapy or had undertaken the Optifast® program. For the 20 patients who supposedly lacked a psychosomatic evaluation, an adequate psychosomatic evaluation was carried out in all cases. CONCLUSIONS: The establishment of an operative obesity center can last for several years. A essential prerequisite for success seems to be the constructive and targeted cooperation with the health insurance companies.

[The new patient rights act : the significance for surgeons]. / Zum neuen Patientenrechtegesetz : Bedeutung für den Chirurgen.

The committee draft for the new patient rights act was approved by the Federal Cabinet on 23 May 2012. Both the demands of the patient representative of the Federal government and some of the demands from the cornerstone paper of the State commission were taken into consideration.The draft of the new act contains comprehensive amendments to the Civil Code with the subtitle"Treatment contract in accordance with §630" and encompasses §§630a-h. The valid legal situation is therefore to all intents and purposes now codified.

[Clinical trials in surgery. On the way towards evidence-based surgery]. / Klinische Studien in der Chirurgie. Auf dem Weg zur evidenzbasierten Chirurgie.

The Study Centre of the German Surgical Society (SDGC) aims at a sustainable support of clinical trials in surgery. The SDGC focuses especially on the development and conducting of clinical trials in university and non-academic hospitals. This article outlines current fields of action and future perspectives of the SDGC.

[Surgery and management: natural partners]. / Chirurgie und Management: natürliche Partner.

The term management is a description of the functions: planning, organization, leadership and control in institutions and the corresponding persons holding these powers. In order to efficiently lead a department of surgery, surgeons need to possess management qualities and have to be able to act as team leaders. Good management of a surgical department leads to avoidance of complications and increased profits as well as more efficient use of operating room capacities and a better organization within the department.

[Hospital cooperation models. Safeguarding optimized patient care, medical training and resource utilization]. / Krankenhaus-kooperationsmodelle. Nachhaltige Sicherung einer optimierten Patientenversorgung, Weiterbildung und Ressourcenauslastung.

INTRODUCTION: In the face of continuous medical progress on the one hand and the increasing cost pressure through the diagnosis-related groups (DRG) system with concomitant hospital privatization on the other, pioneering and economical models for modern and competent patient care are required. METHODS: The cooperation model of the surgical department of the Heidelberg University Hospital is based on patient selection according to the grade of disease complexity and has been successfully developed in Heidelberg since 2005. The long-term results on the basis of actual proceeds are presented. RESULTS: Cooperation with the Salem Hospital chaired by the director of the University surgical department has been ongoing for 6 years. General visceral surgery cases with low complexity are treated at the secondary cooperation hospitals whereas complex oncological operations of the esophagus, liver, pancreas, rectum or multivisceral resections and transplantations are performed at the University hospital. Optimal utilization of the operative and infrastructural resources of both cooperation partners lead to an improvement in surgical training and proceeds. Likewise, another cooperation with the secondary hospital in Sinsheim, which started 2 years ago, has shown similar positive results. Clinical rotation for surgical residents and attending surgeons guarantee a complete and competent surgical training in the field of general surgery. CONCLUSIONS: The long-term results indicate that the cooperation model functions to achieve an optimized treatment of patients and an economical win-win situation for all cooperation partners by differential utilization of the available resources in the hospital network.

[Valid liability law in surgery. Principles of legal requirements and clinical benchmarks exemplified by visceral surgery]. / Über das geltende Haftungsrecht in der Chirurgie. Grundsätzliche juristische Vorgaben und klinische Bezugspunkte am Beispiel der Viszeralchirurgie.

The spectacular increase in liability processes in the field of surgery and in particular in visceral surgery, necessitates an objectification of the conflict between surgical medical professionals and medico-legal institutions, firms of solicitors and courts. Out of court settlements assisted by expert opinion commissions of the Medical Council can avoid many legal conflicts. For improvement of the legal standpoint of a defendant medical professional an unambiguous, extensive and detailed documentation of medical examination findings, the indications for the planned operative intervention, extensive and detailed documentation on disclosure and informed consent of the patient for the planned operative intervention, an extensive, detailed careful and responsibly guided report of the operation as well as a systematic, orderly well-planned postoperative complication management are necessary to counter the accusation of an organizational failure of medical professionals and the accused hospital. The mutual building of confidence between surgical medical professionals and legal institutions is safeguarded by a comprehensive documentation and an unambiguous description and formulation of the medical discharge report on termination of inpatient treatment.

[Contribution of the Study Center of the German Surgical Society to evidence based surgery]. / Beitrag des Studienzentrums der Deutschen Gesellschaft für Chirurgie zur evidenzbasierten Chirurgie.

Since the Study Center of the German Surgical Society (SDGC) was established in 2003 it has been supporting surgeons to implement their ideas for multicenter randomized studies. Assistance is provided for development (sample size calculation, protocol, funding application) implementation (submission to ethics committee, data management, monitoring) and analysis (statistical analysis, publication) in close collaboration with biometricians and data managers. Currently more than 2,500 patients have been included in 11 trials. The most complex SDGC study (SYNCHRONOUS) so far with up to 80 participating centers has been activated in September 2011. Furthermore, there is an increasing relevance for systematic reviews and meta analyses with regard to the development of studies and aggregation of results. For this reason a systematic review working group was established within the SDGC. To date 13 publications have been completed and 8 more are underway.

[How much business management does a surgeon need?]. / Wie viel Betriebswirtschaft braucht der Chirurg?

The present day healthcare system in Germany is rapidly changing, even more so after the introduction of diagnosis-related groups. The basic requirements for every surgeon remain manual skills, a profound clinical knowledge and the ability for clinical decision-making even in difficult situations. However, these key elements of surgical education no longer fulfill the requirements for today's leaders in surgery. New requirements, consisting of administrative duties, strategic decision-making and department management are too complex to be made only intuitively. Nowadays surgeons also need a profound education in management skills and knowledge of economic mechanisms in order to run an efficient, profitable, patient-oriented surgical department. Every surgeon who aims at obtaining a leadership position should acquire the necessary knowledge and skills.

[German general and visceral surgery: positioning within the international scientific community]. / Deutsche Allgemein- und Viszeralchirurgie: Positionierung im internationalen wissenschaftlichen Vergleich

BACKGROUND: Assessment of scientific performance is critical for selection committees and research funding. The present work evaluated the standing of German surgical research within the international community. METHODS: A database analysis was performed in December 2009 using the ISI Web of Science. RESULTS: The highest impact factor of surgical journals is currently 8.460 with a median impact of all journals of 1.369. Leading academic surgeons have an h-index of more than 60. German surgeons are within the top five leading researchers in the fields of surgery for esophageal and pancreatic cancer, thyroid, hernia, and liver/kidney transplantation. Among the 50 institutions with most publications on a particular topic, 4-5 German centers are mostly represented. The top positions are in total decisively occupied by leading universities in the USA. CONCLUSION: On the basis of scientific parameters German surgical research can compete with leading international centers in certain fields, but should aim to increase the overall impact of research by publishing more in journals with above average impact factors.

[Organization of clinical research: in general and visceral surgery]. / Organisation der klinischen Forschung: In der Allgemein- und Viszeralchirurgie.

The structural organization of research facilities within a surgical university center should aim at strengthening the department's research output and likewise provide opportunities for the scientific education of academic surgeons. We suggest a model in which several independent research groups within a surgical department engage in research projects covering various aspects of surgically relevant basic, translational or clinical research. In order to enhance the translational aspects of surgical research, a permanent link needs to be established between the department's scientific research projects and its chief interests in clinical patient care. Importantly, a focus needs to be placed on obtaining evidence-based data to judge the efficacy of novel diagnostic and treatment concepts. Integration of modern technologies from the fields of physics, computer science and molecular medicine into surgical research necessitates cooperation with external research facilities, which can be strengthened by coordinated support programs offered by research funding institutions.

Assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomised surgical trial.

OBJECTIVE: To examine the current ethical review process (ERP) of ethics committees in a non-pharmacological trial from the perspective of a clinical investigator. DESIGN: Prospective collection of data at the Study Centre of the German Surgical Society on the duration, costs and administrative effort of the ERP of a randomised controlled multicentre surgical INSECT Trial (INterrupted or continuous Slowly absorbable sutures-Evaluation of abdominal Closure Techniques Trial, ISRCTN 24023541) between November 2003 and May 2005. SETTING: Germany. PARTICIPANTS: 18 ethics committees, including the ethics committee handling the primary approval, responsible overall for 32 clinical sites throughout Germany. 8 ethics committees were located at university medical schools (MSU) and 10 at medical chambers. Duration was measured as days between submission and receipt of final approval, costs in euros and administrative effort by calculation of the product of the total number of different types of documents and the mean number of copies required (primary approval acting as the reference standard). RESULTS: The duration of the ERP ranged from 1 to 176 (median 31) days. The median duration was 26 days at MSUs compared with 34 days at medical chambers. The total cost was euro2947. 1 of 8 ethics committees at universities (euro250) and 8 of 10 at medical chambers charged a median fee of euro162 (mean euro269.70). The administrative effort for primary approval was 30. Four ethics committees required a higher administrative effort for secondary approval (37, 39, 42 and 104). CONCLUSION: The ERP for non-pharmacological multicentre trials in Germany needs improvement. The administrative process has to be standardised: the application forms and the number and content of the documents required should be identical or at least similar. The fees charged vary considerably and are obviously too high for committees located at medical chambers. However, the duration of the ERP was, with some exceptions, excellent. A centralised ethics committee in Germany for multicentre trials such as the INSECT Trial can simplify the ERP for clinical investigators in and outside the country.

[Project "Partnership"--university surgical departments and hospitals for basic and regular medical care. Directing cooperation for the future]. / Projekt Partnerschaft--Universitätsklinik und Krankenhaus der Grund- und Regelversorgung. Wegweisende Kooperation in die Zukunft.

Over the last 20 years, urgently needed changes in the German health care system have forced hospitals to make a flexible adjustment to rising costs and the single handed, almost unmanageable dynamics of technical innovation in medicine. The partnership between the Salem Hospital and the Heidelberg University Hospital represents a pioneering management concept for the future. The alliance between a university surgical department with a basic peripheral hospital provides large advantages to patients, staff, hospitals and cost carriers.

Randomized clinical trial of the influence of local water-filtered infrared A irradiation on wound healing after abdominal surgery.

BACKGROUND: Postoperative local water-filtered infrared A (wIRA) irradiation improves tissue oxygen partial pressure, tissue perfusion and tissue temperature, which are important in wound healing. METHODS: The effect of wIRA irradiation on abdominal wound healing following elective gastrointestinal surgery was evaluated. Some 111 patients undergoing moderate to major abdominal surgery were randomized into one of two groups: wIRA and visible light irradiation (wIRA group) or visible light irradiation alone (control group). Uncovered wounds were irradiated twice a day for 20 min from days 2-10 after operation. RESULTS: Irradiation with wIRA improved postoperative wound healing in comparison to visible light irradiation alone. Main variables of interest were: wound healing assessed on a visual analogue scale (VAS) by the surgeon (median 88.6 versus 78.5 respectively; P < 0.001) or patient (median 85.8 versus 81.0; P = 0.040), postoperative pain (median decrease in VAS score during irradiation 13.4 versus 0; P < 0.001), subcutaneous oxygen tension after irradiation (median 41.6 versus 30.2 mmHg; P < 0.001) and subcutaneous temperature after irradiation (median 38.9 versus 36.4 degrees C; P < 0.001). The overall result, in terms of wound healing, pain and cosmesis, measured on a VAS by the surgeon (median 79.0 versus 46.8; P < 0.001) or patient (79.0 versus 50.2; P < 0.001) was better after wIRA irradiation. CONCLUSION: Postoperative irradiation with wIRA can improve normal postoperative wound healing and may reduce costs in gastrointestinal surgery.

Phase III trial of postoperative cisplatin, interferon alpha-2b, and 5-FU combined with external radiation treatment versus 5-FU alone for patients with resected pancreatic adenocarcinoma -- CapRI: study protocol [ISRCTN62866759].

UNLABELLED: After surgical intervention with curative intention in specialised centres the five-year survival of patients with carcinoma of the exocrine pancreas is only 15%. The ESPAC-1 trial showed an increased five-year survival of 21% achieved with adjuvant chemotherapy. Investigators from the Virginia Mason Clinic have reported a 5-year survival rate of 55% in a phase II trial evaluating adjuvant chemotherapy, immunotherapy and external-beam radiation. DESIGN: The CapRI study is an open, controlled, prospective, randomised multi-centre phase III trial. Patients in study arm A will be treated as outpatients with 5-Fluorouracil; Cisplatin and 3 million units Interferon alpha-2b for 5 1/2 weeks combined with external beam radiation. After chemo-radiation the patients receive continuous 5-FU infusions for two more cycles. Patients in study arm B will be treated as outpatients with intravenous bolus injections of folinic acid, followed by intravenous bolus injections of 5-FU given on 5 consecutive days every 28 days for 6 cycles. A total of 110 patients with specimen-proven R0 or R1 resected pancreatic adenocarcinoma will be enrolled. An interim analysis for patient safety reasons will be done one year after start of recruitment. Evaluation of the primary endpoint will be performed two years after the last patients' enrollment. DISCUSSION: The aim of this study is to evaluate the overall survival period attained by chemo-radiotherapy including interferon alpha 2b administration with adjuvant chemotherapy. The influence of interferon alpha on the effectiveness of the patients' chemoradiation regimen, the toxicity, the disease-free interval and the quality of life are analysed. Different factors are tested in terms of their potential role as predictive markers.

[Relevance of surgical outpatient clinics in academic university centers to health care in Germany]. / Stellenwert einer allgemeinen chirurgischen Hochschulambulanz für die medizinische Patientenversorgung Eine ergänzende Erhebung zur "Deutschen Hochschulambulanzenstudie".

During the observation period between 2001 and 2003, all outpatient surgical therapy, including degrees of urgency, surgical care volume, regional provenance of patients, diagnoses, and referral channels were prospectively analysed at the Surgical Department of the University of Heidelberg, Germany. The data gathered do not merely describe the volume and characteristics of care encountered at this academic surgical institution but also provide further insight into the variability of resource utilisation and associated patient flow. Additionally, a retrospective evaluation using structured interviews and questionnaires was performed to differentiate and quantify patient care, teaching, and research activities. This study illustrates the high relevance of academic outpatient institutions to regional provision of general surgical care in Germany. There is a clear dominance of medical support functions, while research and teaching activities are of only minor relevance and realised particularly in subspecialty clinics. These data should give important stimuli for the future planning of health care in Germany. Outpatient clinics for general surgery appear to be an excellent basis for regional models of integrated health care delivery in the future.