A prospective, multi centre, randomized clinical study to compare the efficacy and safety of Ertapenem 3 days versus Ampicillin - Sulbactam 3 days in the treatment of localized community acquired intra-abdominal infection. (T.E.A. Study: Three days Ertapenem vs three days Ampicillin-sulbactam)

<p>Abstract</p> <p>Background</p> <p>The recommendations outlined in the latest guidelines published by the Surgical Infection Society (SIS) and the Infectious Disease Society of America (IDSA) regarding the proper duration of antibiotic therapy in patients with intra-abdominal infections are limited and non-specific. This ambiguity is due mainly to the lack of clinical trials on the topic of optimal duration of therapy. It is well known that the overuse of antibiotics has several important consequences such as increased treatment costs, reduced clinical efficacy, and above all, the increased emergence of antibiotic-resistant pathogens. Ampicillin-Sulbactam is a commonly used "first line" antibiotic for intra-abdominal infections. Ertapenem and Ampicillin-sulbactam are recommended as primary treatment agents for localized peritonitis by both the SIS and IDSA guidelines.</p> <p>Methods/Design</p> <p>This study is a prospective multi-center randomized investigation. The study will be performed in the Departments of General, Emergency, and Transplant Surgery of Sant'Orsola-Malpighi University Hospital in Bologna, Italy, in the General Surgery Department of the Ospedali Riuniti of Bergamo, Italy, and in the Trauma and Emergency Surgery Department of Maggiore Hospital in Bologna, Italy, and will be conducted by all surgeons willing to participate in the study. The inclusion period of the study will take approximately two years before the planned number of 142 enrolled patients is reached.</p> <p>Discussion</p> <p>Ertapenem and Ampicillin-sulbactam are recommended both as primary treatment agents for localized peritonitis by both the SIS and IDSA guidelines. As one of the discussed topic is the optimal duration of the antibiotic therapy and this ambiguity is due mainly to the lack of clinical trials on the topic, the present study aims for obtain precise data.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00630513">NCT00630513</a></p

The challenges faced in the design, conduct and analysis of surgical randomised controlled trials

Randomised evaluations of surgical interventions are rare; some interventions have been widely adopted without rigorous evaluation. Unlike other medical areas, the randomised controlled trial (RCT) design has not become the default study design for the evaluation of surgical interventions. Surgical trials are difficult to successfully undertake and pose particular practical and methodological challenges. However, RCTs have played a role in the assessment of surgical innovations and there is scope and need for greater use. This article will consider the design, conduct and analysis of an RCT of a surgical intervention. The issues will be reviewed under three headings: the timing of the evaluation, defining the research question and trial design issues. Recommendations on the conduct of future surgical RCTs are made. Collaboration between research and surgical communities is needed to address the distinct issues raised by the assessmentof surgical interventions and enable the conduct of appropriate and well-designed trials.The Health Services Research Unit is funded by the Scottish Government Health DirectoratesPeer reviewedPublisher PD

Single port/incision laparoscopic surgery compared with standard three-port laparoscopic surgery for appendicectomy : a randomised controlled trial

PMID: 23111090 [PubMed - indexed for MEDLINE] PMCID: PMC3543288 Free PMC ArticlePeer reviewedPublisher PD

Adoption of an innovation to repair aortic aneurysms at a Canadian hospital: a qualitative case study and evaluation

<p>Abstract</p> <p>Background</p> <p>Priority setting in health care is a challenge because demand for services exceeds available resources. The increasing demand for less invasive surgical procedures by patients, health care institutions and industry, places added pressure on surgeons to acquire the appropriate skills to adopt innovative procedures. Such innovations are often initiated and introduced by surgeons in the hospital setting. Decision-making processes for the adoption of surgical innovations in hospitals have not been well studied and a standard process for their introduction does not exist. The purpose of this study is to describe and evaluate the decision-making process for the adoption of a new technology for repair of abdominal aortic aneurysms (endovascular aneurysm repair [EVAR]) in an academic health sciences centre to better understand how decisions are made for the introduction of surgical innovations at the hospital level.</p> <p>Methods</p> <p>A qualitative case study of the decision to adopt EVAR was conducted using a modified thematic analysis of documents and semi-structured interviews. Accountability for Reasonableness was used as a conceptual framework for fairness in priority setting processes in health care organizations.</p> <p>Results</p> <p>There were two key decisions regarding EVAR: the decision to adopt the new technology in the hospital and the decision to stop hospital funding. The decision to adopt EVAR was based on perceived improved patient outcomes, safety, and the surgeons' desire to innovate. This decision involved very few stakeholders. The decision to stop funding of EVAR involved all key players and was based on criteria apparent to all those involved, including cost, evidence and hospital priorities. Limited internal communications were made prior to adopting the technology. There was no formal means to appeal the decisions made.</p> <p>Conclusion</p> <p>The analysis yielded recommendations for improving future decisions about the adoption of surgical innovations. ese empirical findings will be used with other case studies to help develop guidelines to help decision-makers adopt surgical innovations in Canadian hospitals.</p

Burn wounds infected with Pseudomonas aeruginosa triggers weight loss in rats

BACKGROUND: Despite dramatic improvements in the management of burns, infection still remains a serious risk for the burn patient. The aim of this study was to shed light on the impact of acute burn injury with or without infection on cytokine profiles. METHODS: Sprague-Dawley rats (n = 21) were randomized into three groups: 1) burn only 2) burn and infection or 3) sham burn. Weight was monitored and blood was collected for cytokine ELISA, LPS quantification, and peripheral blood analysis. Animals were sacrificed either after 6 or 12 days. RESULTS: Infected animals showed substantial weight loss until day 6 post-burn as compared to burn alone. Endotoxin and TNF-α levels were elevated early in the infected burn group within 48 hours post-burn. In contrast, significant up-regulation of the anti-inflammatory cytokine IL-10 occurred later in the clinical course and was associated with the recovery from weight loss. CONCLUSION: Our results suggest that in the presence of infection, you get a SIRS response possibly due to transient endotoxemia that is only seen in the infection group. In contrast, both burn and infection get a late IL-10 (CARS) response, which is then associated with a return to normal weight in the infection group