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Well-designed, prospective, multicenter, randomized clinical trials (RCTs) define the gold standard of evidence-based medicine. The results of such trials represent the most solid rationale for therapeutic recommendations in the S3 guideline of medical societies (http://www.leitlinie.de). The performance of studies according to good clinical practice (GCP) guidelines (Guidelines of the International Conference on Harmonization on Good Clinical Practice) is extremely demanding. The findings can shake long established principles and practices to the core. For more than 20 years now, the management of femoral shaft fractures in critically injured patients has been controversially discussed. There are two different concepts competing against each other: Early total care (ETC) aiming at definitive care by immediate femoral nailing and damage control orthopedics (DCO), where nailing is performed at a later time point after initial retention by the use of external fixation. In order to answer this still unresolved question, the Damage Control Study is currently under way involving 25 trauma centers throughout Germany. This study is funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Association), it is endorsed by the board of Deutschen Gesellschaft für Unfallchirurgie (DGU, German Society for Casualty Surgery) and it is embedded in a joint program of the DFG and the Federal Ministry of Education and Research (BMBF) to support clinical studies in Germany. Moreover, the study is supported by the ChirNet Site at Witten/Herdecke-Köln (http://www.chir-net.de). Without a doubt, this RCT is one of the most important studies carried out in the field of care for the critically injured patient, because the results will have a profound influence on the future management of femoral shaft fractures in multiple trauma patients and because successful completion of this study will underline the high scientific competence and skills claimed by German trauma surgeons. At the same time, ironically, the success of this study is endangered by the dilemma of an as yet insufficient recruitment of suitable patients to be enrolled into the trial. In this article possible explanations for this problem will be discussed based on a case report and the specific challenges in performing RCTs that scrutinize questions in the field of surgery will be analyzed.

Background: Many patients still suffer severe acute pain in the postoperative period. Although guidelines for treating acute pain are widely published and promoted, most do not consider procedure-specific differences in pain experienced or in techniques that may be most effective and appropriate for different surgical settings. The procedure-specific postoperative pain management (PROSPECT) Working Group provides procedure-specific recommendations for postoperative pain management together with supporting evidence from systematic literature reviews and related procedures at http://www.postoppain.org, Methods: The methodology for PROSPECT reviews was developed and refined by discussion of the Working Group, and it adapts existing methods for formulation of consensus recommendations to the specific requirements of PROSPECT., Results: To formulate PROSPECT recommendations, we use a methodology that takes into account study quality and source and level of evidence, and we use recognized methods for achieving group consensus, thus reducing potential bias. The new methodology is first applied in full for the 2006 update of the PROSPECT review of postoperative pain management for laparoscopic cholecystectomy., Conclusions: Transparency in PROSPECT processes allows the users to be fully aware of any limitations of the evidence and recommendations, thereby allowing for appropriate decisions in their own practice setting.

Background: Emergency laparoscopic exploration can be used to identify the causative pathology of acute abdominal pain. Laparoscopic surgery also allows treatment of many intraabdominal disorders. This report was prepared to describe the effectiveness of laparoscopic surgery compared to laparotomy or nonoperative treatment., Methods: A panel of European experts in abdominal and gynecological surgery was assembled and participated in a consensus conference using Delphi methods. The aim was to develop evidence-based recommendations for the most common diseases that may cause acute abdominal pain., Recommendations: Laparoscopic surgery was found to be clearly superior for patients with a presumable diagnosis of perforated peptic ulcer, acute cholecystitis, appendicitis, or pelvic inflammatory disease. In the emergency setting, laparoscopy is of unclear or limited value if adhesive bowel obstruction, acute diverticulitis, nonbiliary pancreatitis, hernia incarceration, or mesenteric ischemia are suspected. In stable patients with acute abdominal pain, noninvasive diagnostics should be fully exhausted before considering explorative surgery. However, diagnostic laparoscopy may be useful if no diagnosis can be found by conventional diagnostics. More clinical data are needed on the use of laparoscopy after blunt or penetrating trauma of the abdomen., Conclusions: Due to diagnostic and therapeutic advantages, laparoscopic surgery is useful for the majority of conditions underlying acute abdominal pain, but noninvasive diagnostic aids should be exhausted first. Depending on symptom severity, laparoscopy should be advocated if routine diagnostic procedures have failed to yield results.

The PROSPECT Working Group, a collaboration of anaesthetists and surgeons, conducts systematic reviews of postoperative pain management for different surgical procedures ( ). Evidence-based consensus recommendations for the effective management of postoperative pain are then developed from these systematic reviews, incorporating clinical practice observations, and transferable evidence from other relevant procedures. We present the results of a systematic review of pain and other outcomes following analgesic, anaesthetic and surgical interventions for total knee arthroplasty (TKA). The evidence from this review supports the use of general anaesthesia combined with a femoral nerve block for surgery and postoperative analgesia, or alternatively spinal anaesthesia with local anaesthetic plus spinal morphine. The primary technique, together with cooling and compression techniques, should be supplemented with paracetamol and conventional non-steroidal anti-inflammatory drugs or COX-2-selective inhibitors, plus intravenous strong opioids (high-intensity pain) or weak opioids (moderate- to low-intensity pain). [ABSTRACT FROM AUTHOR]