amoxicillin-potassium-clavulanate-combination and Cholecystitis--Acute

Ninety percent of cases of acute calculous cholecystitis are of mild (grade I) or moderate (grade II) severity. Although the preoperative and intraoperative antibiotic management of acute calculous cholecystitis has been standardized, few data exist on the utility of postoperative antibiotic treatment.. To determine the effect of postoperative amoxicillin plus clavulanic acid on infection rates after cholecystectomy.. A total of 414 patients treated at 17 medical centers for grade I or II acute calculous cholecystitis and who received 2 g of amoxicillin plus clavulanic acid 3 times a day while in the hospital before and once at the time of surgery were randomized after surgery to an open-label, noninferiority, randomized clinical trial between May 2010 and August 2012.. After surgery, no antibiotics or continue with the preoperative antibiotic regimen 3 times daily for 5 days.. The proportion of postoperative surgical site or distant infections recorded before or at the 4-week follow-up visit.. An imputed intention-to-treat analysis of 414 patients showed that the postoperative infection rates were 17% (35 of 207) in the nontreatment group and 15% (31 of 207) in the antibiotic group (absolute difference, 1.93%; 95% CI, -8.98% to 5.12%). In the per-protocol analysis, which involved 338 patients, the corresponding rates were both 13% (absolute difference, 0.3%; 95% CI, -5.0% to 6.3%). Based on a noninferiority margin of 11%, the lack of postoperative antibiotic treatment was not associated with worse outcomes than antibiotic treatment. Bile cultures showed that 60.9% were pathogen free. Both groups had similar Clavien complication severity outcomes: 195 patients (94.2%) in the nontreatment group had a score of 0 to I and 2 patients (0.97%) had a score of III to V, and 182 patients (87.8%) in the antibiotic group had a score of 0 to I and 4 patients (1.93%) had a score of III to V.. Among patients with mild or moderate calculous cholecystitis who received preoperative and intraoperative antibiotics, lack of postoperative treatment with amoxicillin plus clavulanic acid did not result in a greater incidence of postoperative infections.. clinicaltrials.gov Identifier: NCT01015417.

Topics: Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cholecystectomy; Cholecystitis, Acute; Female; Humans; Male; Middle Aged; Postoperative Care; Postoperative Complications; Treatment Outcome; Young Adult

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cholangiography; Cholecystectomy; Cholecystectomy, Laparoscopic; Cholecystitis, Acute; Choledocholithiasis; Endoscopy, Gastrointestinal; Female; Humans; Male; Postoperative Complications

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cholecystectomy; Cholecystitis, Acute; Female; Humans; Male; Postoperative Complications

The objective of the study was to analyze surgical site infection (SSI) frequency with different duration antibiotic courses to establish the minimum necessary duration.. This is an observational study of prospective surveillance of 287 consecutive patients (mean age 67.8 years) operated on for acute cholecystitis of grade II severity in the first 72 h. Postoperative antibiotics had been withdrawn before diagnosis of any infection as an inclusion criterion. Patients were classified into three groups, according to therapy duration: group 1 (0-4 days, n = 45, 15.7 %); group 2 (5-7 days, n = 75, 26.1 %); and group 3 (>7 days, n = 167, 58.2 %). A multivariable analysis of risk infection was performed.. Overall SSI frequency in groups 1, 2, and 3 was 2.2, 10.7, and 9 %, respectively. Risk analysis showed an increase in both crude and adjusted relative risks of overall infection in group 2 (crude relative risk (RR): 4.80 (0.62-37.13); adjusted RR, 2.03 (0.20-20.91)) and in group 3 (crude RR, 4.04 (0.55-29.79); adjusted RR, 2.35 (0.28-20.05)) by comparison with group 1, although without statistical significance. As a result, treatment lasting 4 days or less was not associated with overall surgical site infection incidence higher than longer treatment.. Antibiotic treatment over 4 days after early cholecystectomy provides no advantage in decreasing surgical site infection incidence.

Topics: Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotic Prophylaxis; Cholecystectomy; Cholecystitis, Acute; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Postoperative Care; Prospective Studies; Risk Assessment; Surgical Wound Infection; Time Factors