Effect of oral antimicrobial prophylaxis on surgical site infection after elective colorectal surgery: multicentre, randomised, double blind, placebo controlled trial.

OBJECTIVE: To investigate whether oral antimicrobial prophylaxis as an adjunct to intravenous antibiotic prophylaxis reduces surgical site infections after elective colorectal surgery. DESIGN: Multicentre, randomised, double blind, placebo controlled trial. SETTING: 11 university and non-university hospitals in France between 25 May 2016 and 8 August 2019. PARTICIPANTS: 926 adults scheduled for elective colorectal surgery. INTERVENTION: Patients were randomised to receive either a single 1 g dose of ornidazole (n=463) or placebo (n=463) orally 12 hours before surgery, in addition to intravenous antimicrobial prophylaxis before surgical incision. MAIN OUTCOME MEASURES: The primary outcome was the proportion of patients with surgical site infection within 30 days after surgery. Secondary outcomes included individual types of surgical site infections and major postoperative complications (Clavien-Dindo classification grade 3 or higher) within 30 days after surgery. RESULTS: Of the 960 patients who were enrolled, 926 (96%) were included in the analysis. The mean age of participants was 63 years and 554 (60%) were men. Surgical site infection within 30 days after surgery occurred in 60 of 463 patients (13%) in the oral prophylaxis group and 100 of 463 (22%) in the placebo group (absolute difference -8.6%, 95% confidence interval -13.5% to -3.8%; relative risk 0.60, 95% confidence interval 0.45 to 0.80). The proportion of patients with deep infections was 4.8% in the oral prophylaxis group and 8.0% in the placebo group (absolute difference -3.2%, 95% confidence interval -6.4% to -0.1%). The proportion of patients with organ space infections was 5.0% in the oral prophylaxis group and 8.4% in the placebo group (absolute difference -3.4%, -6.7% to -0.2%). Major postoperative complications occurred in 9.1% patients in the oral prophylaxis group and 13.6% in the placebo group (absolute difference -4.5%, -8.6% to -0.5%). CONCLUSION: Among adults undergoing elective colorectal surgery, the addition of a single 1 g dose of ornidazole compared with placebo before surgery significantly reduced surgical site infections. TRIAL REGISTRATION: ClinicalTrials.gov NCT02618720.

Impact of a procalcitonin-based algorithm on the quality of management of patients with uncomplicated adhesion-related small bowel obstruction assessed by a textbook outcome: a multicenter cluster-randomized open-label controlled trial.

BACKGROUND: Acute adhesion-related small bowel obstruction (ASBO) is a common digestive emergency, accounting for 1 to 3% of all digestive emergencies. The efficacy of conservative management in this setting is a subject of debate, as it may delay the decision to perform surgery and increase the frequency of bowel resection (e.g., in the presence of bowel necrosis) or, in contrast, prompt an excessive number of unnecessary laparotomies. Thus, the decision to perform surgery is difficult. We propose that the introduction of the procalcitonin (PCT)-based algorithm improves the quality of the management of patients with ASBO by aiding the decision of whether or not to perform surgery. METHODS: This is a 1:1 cluster-randomized clinical trial (use of algorithm: no algorithm) using an independent computer to ensure that investigators cannot interfere with the randomization. Each cluster will correspond to one investigating center. All patients in a center will be managed in the same way. Before randomization, each principal investigator will provide a commitment to participate in the study to avoid the risk of "empty clusters". The patients included will constitute two parallel arms (use of algorithm versus no algorithm), with no expected crossover between arms. The inclusion criteria are being an adult with uncomplicated acute ASBO (i.e., absence of fever, abdominal pain and distension, nausea and/or vomiting, and the absence of gas and/or stool, in conjunction with a contrast-enhanced CT scan, for patients with previous abdominal surgery) who is able to express consent with a signed written informed consent form. Patients with complicated acute ASBO (strangulation or peritonitis) will be excluded. DISCUSSION: There is an ongoing debate on the management of uncomplicated ASBO. The main points are to avoid a surgery if it is unnecessary and to avoid delayed surgery if it is necessary. Currently, there are no robust criteria to objectively determine the failure of non-surgical treatment or to establish the indications for surgery in acute ASBO. Our team proposes the use of procalcitonin (PCT) to help distinguish patients for whom conservative management is likely to be successful from those for whom surgical management is required. The results from a randomized control trial could help in the selection of patients through clear inclusion and exclusion criteria and simplify or clarify the management algorithm. In conclusion, PCT may be useful in evaluating the proper strategy for ASBO. Trial registration The trial is registered at clinical trials under the reference: NCT03905239.

Role of patient education in the perception and acceptance of home monitoring after recent implantation of cardioverter defibrillators: the EDUCAT study.

BACKGROUND: Much attention is being paid to the education of and provision of medical information to patients, to optimize their understanding and acceptance of their disease. AIMS: To ascertain the impact of educating recent recipients of an implantable cardioverter defibrillator (ICD) on their perception and acceptance of a home monitoring (HM) system. METHODS: Questionnaire 1, completed one month after ICD implantation, was designed to assess: the quality of patient preparation for HM; patient comprehension of HM; and patient anxiety experienced during its installation. The comprehension questions were assigned a score of -2 for an incorrect answer, +1 for a correct answer and 0 for neither (total score ranging from -40 to +20). Questionnaire 2, completed six months after ICD implantation, assessed patient acceptance of and anxiety about HM. RESULTS: The registry included 571 patients (mean age 63.9±12.8 years; 83% men; 76% of ICDs implanted for primary prevention) followed by HM for 6.2±1.2 months. Questionnaire 1 was completed by 430 (75.3%) patients and questionnaire 2 by 398 (69.7%) patients. Younger patients had a better comprehension of HM than older patients. High-quality training conditions improved the comprehension score, and a positive association was observed between anxiety and acceptance levels and the comprehension score. The 80±20% mean data transmission rate (days of transmission/days of follow-up ratio) was unrelated to the comprehension scores. CONCLUSION: A clear understanding was associated with a higher acceptance of HM, although it was unrelated to the data transmission rate.

Radio-frequency ablation of atrial flutter: long-term results and predictive value of cavo-tricuspid isthmus bidirectional block as determined by a simplified technique.

OBJECTIVES: Complete bidirectional cavo-tricuspid isthmus (CTI) block is mandatory for radio-frequency (RF) ablation of typical atrial flutter (AF). CTI block can be assessed by a simplified method using two catheters and the technique of differential pacing, but long-term results in large series are poorly known. METHODS: CTI RF ablation was performed in 255 consecutive patients with typical AF, using one quadripolar catheter, and the ablation catheter, in association with the technique of differential pacing. RESULTS: Procedural success, as defined by documentation of complete bidirectional CTI block using limited activation mapping, positive differential pacing together with termination of ongoing AF, was achieved in 80% of patients. AF recurred in 37 patients (14%) over a mean follow-up period of 15 +/- 9 months. Two hundred and forty-one patients (94%) were finally cured, with 1.1 procedures/patient. The recurrence rate was related to the achievement of complete CTI bidirectional block (12% vs. 29%, p = 0.01). CONCLUSIONS: Long-term results of CTI ablation, employing a simplified method using the differential pacing technique, are similar to those for the standard methods using multipolar catheters. Therefore, this technique compares favorably to other established methods for such common RF procedures, especially due to its lower cost.

A second liver resection due to recurrent colorectal liver metastases.

BACKGROUND: Repeat liver resection because of recurrent colorectal liver metastases can provide survival benefit with a low rate of complications. DESIGN: Retrospective study. PARTICIPANTS: Forty patients who underwent a second hepatectomy because of liver metastases from colorectal cancer. MAIN OUTCOME MEASURES: Short- and long-term results of a second hepatectomy and determination of prognostic factors. RESULTS: The postoperative mortality rate was 2.5%. The postoperative morbidity rate was not significantly different after a second hepatectomy compared with single hepatectomy (42.5% and 27.5%, respectively; P = .10). Transfusion requirement and hospital stay were comparable for both a single and a second hepatectomy. Three- and 5-year overall survival rates were 55% and 31%, respectively. Disease-free survival rates at 3 and 5 years were, respectively, 49% and 27%. The interval between first and second hepatectomies and the presence of extrahepatic disease were independently related to survival (multivariate analysis). CONCLUSIONS: A second liver resection because of recurrent liver metastases from colorectal cancer is safe and provides a survival benefit similar to that with single hepatectomy. Our analysis suggests that the benefit of treatment is limited in patients who undergo a second hepatectomy within 1 year of the first operation and in those with extrahepatic disease.

Resumption of atrioventricular conduction by levosimendan after radiofrequency ablation of the AV node:.

We report the case of a patient in whom radiofrequency catheter ablation of the AV node was initially successfully performed for persistent atrial fibrillation with fast ventricular rate, but in whom atrioventricular conduction transiently resumes following therapy with levosimendan. Plausible hypothesis are discussed as well as potential implications.