A NSQIP-based randomized clinical trial evaluating choice of prophylactic antibiotics for pancreaticoduodenectomy.
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ABSTRACT:
SUBMITTER: Brajcich BC
PROVIDER: S-EPMC8041048 | biostudies-literature | 2021 May
REPOSITORIES: biostudies-literature
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A NSQIP-based randomized clinical trial evaluating choice of prophylactic antibiotics for pancreaticoduodenectomy.
Brajcich Brian C BC Ko Clifford Y CY Liu Jason B JB Ellis Ryan J RJ D Angelica Michael I MI
Journal of surgical oncology 20210501 6
Surgical site infection after pancreaticoduodenectomy is often caused by pathogens resistant to standard prophylactic antibiotics, suggesting that broad-spectrum antibiotics may be more effective prophylactic agents. This article describes the rationale and methodology underlying a multicenter randomized trial evaluating piperacillin-tazobactam compared with cefoxitin for surgical site infection prevention following pancreaticoduodenectomy. As the first US randomized surgical trial to utilize a ...[more]
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Project description:ImportanceMultiple-dose antibiotic prophylaxis is widely used to prevent infection after implant-based breast reconstruction despite the lack of high-level evidence regarding its clinical benefit.ObjectiveTo determine whether multiple-dose antibiotic prophylaxis is superior to single-dose antibiotic prophylaxis in preventing surgical site infection (SSI) after implant-based breast reconstruction.Design, setting, and participantsThis prospective, multicenter, randomized clinical superiority trial was conducted at 7 hospitals (8 departments) in Sweden from April 25, 2013, to October 31, 2018. Eligible participants were women aged 18 years or older who were planned to undergo immediate or delayed implant-based breast reconstruction. Follow-up time was 12 months. Data analysis was performed from May to October 2021.InterventionsMultiple-dose intravenous antibiotic prophylaxis extending over 24 hours following surgery, compared with single-dose intravenous antibiotic. The first-choice drug was cloxacillin (2 g per dose). Clindamycin was used (600 mg per dose) for patients with penicillin allergy.Main outcomes and measuresThe primary outcome was SSI leading to surgical removal of the implant within 6 months after surgery. Secondary outcomes were the rate of SSIs necessitating readmission and administration of intravenous antibiotics, and clinically suspected SSIs not necessitating readmission but oral antibiotics.ResultsA total of 711 women were assessed for eligibility, and 698 were randomized (345 to single-dose and 353 to multiple-dose antibiotics). The median (range) age was 47 (19-78) years for those in the multiple-dose group and 46 (25-76) years for those in the single-dose group. The median (range) body mass index was 23 (18-38) for the single-dose group and 23 (17-37) for the multiple-dose group. Within 6 months of follow-up, 30 patients (4.3%) had their implant removed because of SSI. Readmission for intravenous antibiotics because of SSI occurred in 47 patients (7.0%), and 190 women (27.7%) received oral antibiotics because of clinically suspected SSI. There was no significant difference between the randomization groups for the primary outcome implant removal (odds ratio [OR], 1.26; 95% CI, 0.69-2.65; P = .53), or for the secondary outcomes readmission for intravenous antibiotics (OR, 1.18; 95% CI, 0.65-2.15; P = .58) and prescription of oral antibiotics (OR, 0.72; 95% CI, 0.51-1.02; P = .07). Adverse events associated with antibiotic treatment were more common in the multiple-dose group than in the single-dose group (16.4% [58 patients] vs 10.7% [37 patients]; OR, 1.64; 95% CI, 1.05-2.55; P = .03).Conclusions and relevanceThe findings of this randomized clinical trial suggest that multiple-dose antibiotic prophylaxis is not superior to a single-dose regimen in preventing SSI and implant removal after implant-based breast reconstruction but comes with a higher risk of adverse events associated with antibiotic treatment.Trial registrationEudraCT 2012-004878-26.
| S-EPMC9482055 | biostudies-literature
Project description:ImportanceThe benefits of prophylactic antibiotics for hospitalized patients with severe alcohol-related hepatitis are unclear.ObjectiveTo determine the efficacy of amoxicillin-clavulanate, compared with placebo, on mortality in patients hospitalized with severe alcohol-related hepatitis and treated with prednisolone.Design, setting, and participantsMulticenter, randomized, double-blind clinical trial among patients with biopsy-proven severe alcohol-related hepatitis (Maddrey function score ≥32 and Model for End-stage Liver Disease [MELD] score ≥21) from June 13, 2015, to May 24, 2019, in 25 centers in France and Belgium. All patients were followed up for 180 days. Final follow-up occurred on November 19, 2019.InterventionPatients were randomly assigned (1:1 allocation) to receive prednisolone combined with amoxicillin-clavulanate (n = 145) or prednisolone combined with placebo (n = 147).Main outcome and measuresThe primary outcome was all-cause mortality at 60 days. Secondary outcomes were all-cause mortality at 90 and 180 days; incidence of infection, incidence of hepatorenal syndrome, and proportion of participants with a MELD score less than 17 at 60 days; and proportion of patients with a Lille score less than 0.45 at 7 days.ResultsAmong 292 randomized patients (mean age, 52.8 [SD, 9.2] years; 80 [27.4%] women) 284 (97%) were analyzed. There was no significant difference in 60-day mortality between participants randomized to amoxicillin-clavulanate and those randomized to placebo (17.3% in the amoxicillin-clavulanate group and 21.3% in the placebo group [P = .33]; between-group difference, -4.7% [95% CI, -14.0% to 4.7%]; hazard ratio, 0.77 [95% CI, 0.45-1.31]). Infection rates at 60 days were significantly lower in the amoxicillin-clavulanate group (29.7% vs 41.5%; mean difference, -11.8% [95% CI, -23.0% to -0.7%]; subhazard ratio, 0.62; [95% CI, 0.41-0.91]; P = .02). There were no significant differences in any of the remaining 3 secondary outcomes. The most common serious adverse events were related to liver failure (25 in the amoxicillin-clavulanate group and 20 in the placebo group), infections (23 in the amoxicillin-clavulanate group and 46 in the placebo group), and gastrointestinal disorders (15 in the amoxicillin-clavulanate group and 21 in the placebo group).Conclusion and relevanceIn patients hospitalized with severe alcohol-related hepatitis, amoxicillin-clavulanate combined with prednisolone did not improve 2-month survival compared with prednisolone alone. These results do not support prophylactic antibiotics to improve survival in patients hospitalized with severe alcohol-related hepatitis.Trial registrationClinicalTrials.gov Identifier: NCT02281929.
| S-EPMC10170332 | biostudies-literature
Project description:BackgroundAn increasing body of literature is supporting the safety of minimally invasive pancreaticoduodenectomy compared to open pancreaticoduodenectomy, but there are limited comparative studies between laparoscopic and robotic pancreaticoduodenectomy. The aim of this study was to compare the rate of postoperative 30-day overall complications between laparoscopic and robotic pancreaticoduodenectomy.MethodsPatients who underwent laparoscopic and robotic pancreaticoduodenectomy were abstracted from the 2014-2015 pancreas-targeted American College of Surgeons National Surgical Quality Improvement Program. A multivariable logistic regression model was developed to determine if the type of minimally invasive approach was associated with 30-day overall complications.ResultsWe identified 428 minimally invasive pancreaticoduodenectomy cases, of which 235 (55%) were performed laparoscopically and 193 (45%) robotically. Patients who underwent the robotic approach were more likely to be white compared to those who underwent the laparoscopic approach and were less likely to have pulmonary disease, undergo preoperative radiotherapy, and have vascular and multivisceral resection. On multivariable analysis, we found that the type of minimally invasive approach, whether laparoscopic or robotic, was not associated with overall complications. The predictors of 30-day overall complications were higher body mass index (odds ratio [OR], 1.05; 95% confidence interval [CI], 1.02-1.09), vascular resection (OR, 2.10; 95% CI, 1.23-3.58), and longer operative time (OR, 1.002; 95% CI, 1.001-1.004).ConclusionsRobotic pancreaticoduodenectomy was associated with a similar 30-day overall complication rate to laparoscopic pancreaticoduodenectomy. Further studies are needed to corroborate these findings and to establish the best approach to perform this complex operation.
| S-EPMC5789456 | biostudies-literature
Project description:OBJECTIVE:To examine the rate of surgical site infection according to the choice of antibiotics in women undergoing cesarean delivery. METHODS:We conducted a retrospective cohort study of women undergoing cesarean delivery (labored, unlabored, and scheduled) from 2012 to 2017. Women with chorioamnionitis and those who did not receive any antibiotics were excluded. Our primary outcome was defined a priori as a composite of cellulitis, endometritis, deep wound infection, abdominopelvic abscess, and sepsis. Outcomes were examined according to the choice of antibiotics: cefazolin, a standard alternative (both clindamycin and gentamicin), and inappropriate alternatives (such as clindamycin only). A multivariable logistic regression model was used to calculate the propensity score for each observation, which was the probability of receiving a particular antibiotic regimen. The propensity score-adjusted logistic regression models were conducted to calculate adjusted odds ratios (ORs) and 95% CIs. Firth's penalized likelihood approach was applied to address issues of rare events. RESULTS:Among 6,584 selected women, 6,163 (93.6%), 274 (4.2%), and 147 (2.2%) received cefazolin, a standard alternative, and inappropriate alternatives, respectively. Use of standard alternative antibiotics compared with cefazolin was not associated with increased odds of the primary outcome (crude OR 1.50 [0.92-2.46]; adjusted OR 1.63 [0.97-2.60]) but was associated with increased odds of cellulitis (crude OR 2.07 [1.16-3.70]; adjusted OR 1.93 [1.03-3.31]). Use of inappropriate alternative antibiotics compared with cefazolin was associated with increased odds of the primary outcome (crude OR 4.37 [2.80-6.83]; adjusted OR 4.13 [2.59-6.36]) as well as some components of the composite outcome such as endometritis before discharge (crude OR 6.85 [3.94-11.90]; adjusted OR 6.68 [3.69-11.44]) and cellulitis (crude OR 3.36 [1.78-6.34]; adjusted OR 3.23 [1.63-5.81]). CONCLUSION:Both standard alternative and inappropriate alternatives were associated with increased odds of surgical site infections compared with cefazolin.
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Project description:No prospective data have been described to inform guidelines on antibiotic prophylaxis for partial vulvectomies. Thus, we conducted a single-center, pilot, double-blind randomized controlled trial to assess the effectiveness of prophylactic antibiotics to prevent wound complications after partial vulvectomies. Patients were randomly assigned 1:1 to preoperative antibiotics or no preoperative antibiotics. The primary outcome of 30-day postoperative wound complications occurred in 31 (62 %) of all patients, with no differences between groups. The most common wound complications were superficial separation (54.2 % antibiotic prophylaxis vs. 65.3 % no prophylaxis, p = 0.37) and surgical site infection (0 % antibiotic prophylaxis vs 7.7 % no prophylaxis, p = 0.49). However, this study was limited by differences in patient characteristics between the groups. This study provides data to perform power calculations for a trial examining the effect of preoperative antibiotics on surgical site infection.
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Project description:Bifidobacterium and Lactobacillus Probiotics and Gut Dysbiosis in Preterm Infants: The PRIMAL Randomized Clinical Trial
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| PRJEB85138 | ENA
Project description:IntroductionThe incidence of postendoscopic retrograde cholangiopancreatography (ERCP) infections is reported to be up to 18% in patients with biliary obstruction. Antibiotic prophylaxis may reduce the risk of infectious complications after ERCP; however, the clinical value of prophylactic antibiotics in ERCP remains controversial.MethodsWe conducted a double-blind, placebo-controlled, randomized trial to investigate whether the use of prophylactic antibiotics would reduce infectious complications after ERCP in patients with biliary obstruction. We randomly assigned patients in a 1:1 ratio to receive either a single dose of 1 g intravenous cefoxitin or normal saline as a placebo 30 minutes before undergoing ERCP. The primary outcome was the incidence of infectious complications after ERCP.ResultsWe enrolled 378 patients, and 189 patients were assigned to each group. The risk of infectious complications after ERCP was 2.8% (5 of 176 patients) in the antibiotic prophylaxis group and 9.8% (17 of 173 patients) in the placebo group (risk ratio, 0.29; 95% confidence interval [CI], 0.11-0.74, P = 0.0073). The incidence rates of bacteremia were 2.3% (4 of 176 patients) and 6.4% (11 of 173 patients), respectively (risk ratio, 0.36; 95% CI, 0.12-1.04; P = 0.0599). The incidence rate of cholangitis was 1.7% (3 of 176 patients) in the antibiotic prophylaxis group and 6.4% (11 of 173 patients) in the placebo group (risk ratio, 0.27; 95% CI, 0.08-0.87; P = 0.0267).DiscussionAntibiotic prophylaxis before ERCP in patients with biliary obstruction resulted in a significantly lower risk of infectious complications, especially cholangitis, than placebo ( ClinicalTrials.gov trial number NCT02958059).
| S-EPMC10758346 | biostudies-literature
Project description:ImportanceAlthough standardization of pancreaticoduodenectomy (PD) has improved postoperative outcomes, morbidity remains high. Fast-track surgery programs appear to improve morbidity, and avoiding nasogastric tube decompression (NGTD), already outdated in most major abdominal surgery, is strongly suggested after PD by fast-track surgery programs but lacks high-level evidence, especially regarding safety.ObjectiveTo assess in a randomized clinical trial whether the absence of systematic NGTD after PD reduces postoperative complications.Design, setting, and participantsThe IPOD study (Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy) was an open-label, prospective, single-center, randomized clinical trial conducted at a high-volume pancreatic surgery university hospital in France. In total, 155 patients who were 18 to 75 years of age and required PD for benign or malignant disease were screened for study eligibility. Key exclusion criteria were previous gastric or esophageal surgery and severe comorbidities. Patients were randomly assigned (1:1) to systematic NGTD or to no nasogastric decompression and were followed up until 90 days after surgery.InterventionsFor patients without NGTD, the NGT was removed immediately after surgery, whereas for patients with NGTD, the NGT was removed 3 to 5 days after surgery.Main outcomes and measuresThe primary end point was the occurrence of postoperative complications grade II or higher using the Clavien-Dindo classification. The primary end point and safety were evaluated in the intent-to-treat population.ResultsFrom January 2016 to August 2018, 125 screened patients were considered eligible for the study, and 111 were randomized to no NGTD (n = 52) or to NGTD (n = 59). No patient was lost to follow-up. The 2 groups had similar patient demographic and clinical characteristics at baseline. The median (interquartile range) age was 63.0 (57.0-66.5) years in the group with NGTD (38 [64.4%] were males) and 64.0 (58.0-68.0) years in the group without NGTD (31 [59.6%] were males). The postoperative complication rates grade II or higher were similar between the 2 groups (risk ratio, 0.99; 95% CI, 0.66-1.47; P > .99). Pulmonary complication rates (risk ratio, 0.59; 95% CI, 0.18-1.95; P = .44) and delayed gastric emptying rates (risk ratio, 1.07; 95% CI, 0.52-2.21; P > .99) were not significantly different between the groups. Median (interquartile) length of hospital stay for patients without NGTD was not significantly different compared with those with NGTD (10.0 [9.0-16.3] vs 12.0 [10.0-16.0] days; P = .14).Conclusions and relevanceThe present study found no significant difference in postoperative complication occurrence of Clavien-Dindo classification grade II or higher between systematic NGTD and no NGTD after PD, suggesting that avoiding systematic nasogastric decompression is safe for this indication.Trial registrationClinicalTrials.gov Identifier: NCT02594956.
| S-EPMC7364368 | biostudies-literature
Project description:BackgroundThe estimated annual global burden of miscarriage is 33 million out of 210 million pregnancies. Many women undergoing miscarriage have surgery to remove pregnancy tissues, resulting in miscarriage surgery being one of the most common operations performed in hospitals in low-income countries. Infection is a serious consequence and can result in serious illness and death. In low-income settings, the infection rate following miscarriage surgery has been reported to be high. Good quality evidence on the use of prophylactic antibiotics for surgical miscarriage management is not available. Given that miscarriage surgery is common, and infective complications are frequent and serious, prophylactic antibiotics may offer a simple and affordable intervention to improve outcomes.MethodsEligible patients will be approached once the diagnosis of miscarriage has been made according to local practice. Once informed consent has been given, participants will be randomly allocated using a secure internet facility (1:1 ratio) to a single dose of oral doxycycline (400 mg) and metronidazole (400 mg) or placebo. Allocation will be concealed to both the patient and the healthcare providers. A total of 3400 women will be randomised, 1700 in each arm. The medication will be given approximately 2 hours before surgery, which will be provided according to local practice. The primary outcome is pelvic infection 2 weeks after surgery. Women will be invited to the hospital for a clinical assessment at 2 weeks. Secondary outcomes include overall antibiotic use, individual components of the primary outcome, death, hospital admission, unplanned consultations, blood transfusion, vomiting, diarrhoea, adverse events, anaphylaxis and allergy, duration of clinical symptoms, and days before return to usual activities. An economic evaluation will be performed to determine if prophylactic antibiotics are cost-effective.DiscussionThis trial will assess whether a single dose of doxycycline (400 mg) and metronidazole (400 mg) taken orally 2 hours before miscarriage surgery can reduce the incidence of pelvic infection in women up to 2 weeks after miscarriage surgery.Trial registrationRegistered with the ISRCTN (international standard randomised controlled trial number) registry: ISRCTN 97143849 . (Registered on April 17, 2013).
| S-EPMC5914072 | biostudies-literature