BACKGROUND:Laparoscopic cholecystectomy uses smaller incision and trocars that lessen the contamination and exposure of wound, resulting in less infection. However, the antibiotic prophylaxis is still widely practiced, like in our institute, a continuation of the era of open surgery. Recent studies reveal no advantage of routine use of antibiotic, and there is growing consensus against it. Besides cost, antibiotic increases emergence of multidrug resistance. Because of the controversies, we conducted this clinical trial. METHODS: This randomized clinical trial, conducted from October 1, 2009 to September 31, 2010 at Patan Hospital, included 154 patients in prophylactic antibiotic group (GrAP) withcefazolin1 g IV as per existing practice and 156 in no antibiotic group (GrAPn). Symptomatic laparoscopic cholecystectomy patients of American Society of Anesthesiologist (ASA) 1 and 2 (without diabetes) were included. Patients with complicated gall stones (cholangitis, choledocholithiasis, and pancreatitis) and who required conversion were excluded. Wound was observed during follow-up within 1 week. Data on patient characteristics, use of antibiotic, bile spillage, and postoperative wound infection were entered in predesigned proforma. Microsoft Excel was used to analyze the data. RESULTS: In total, 310 patients were eligible for analysis, 154 in GrAP and 156 in GrAPn. Both groups were comparable in patient demographic and clinical characteristics such as average age (40.3 vs. 41.6 years) and sex (female 77.6% vs. 78.6%). Overall wound infection occurred in 4.8% (15/310). There was no significant difference in wound infections among the two groups (p = 0.442): GrAP 3.9% and GrAPn 5.8%. There was no mortality in this series. CONCLUSION:Routine preoperative antibiotic prophylaxis is not necessary in low-risk symptomatic gallstone patients undergoing laparoscopic cholecystectomy.
RCT Entities:
BACKGROUND: Laparoscopic cholecystectomy uses smaller incision and trocars that lessen the contamination and exposure of wound, resulting in less infection. However, the antibiotic prophylaxis is still widely practiced, like in our institute, a continuation of the era of open surgery. Recent studies reveal no advantage of routine use of antibiotic, and there is growing consensus against it. Besides cost, antibiotic increases emergence of multidrug resistance. Because of the controversies, we conducted this clinical trial. METHODS: This randomized clinical trial, conducted from October 1, 2009 to September 31, 2010 at Patan Hospital, included 154 patients in prophylactic antibiotic group (GrAP) with cefazolin 1 g IV as per existing practice and 156 in no antibiotic group (GrAPn). Symptomatic laparoscopic cholecystectomy patients of American Society of Anesthesiologist (ASA) 1 and 2 (without diabetes) were included. Patients with complicated gall stones (cholangitis, choledocholithiasis, and pancreatitis) and who required conversion were excluded. Wound was observed during follow-up within 1 week. Data on patient characteristics, use of antibiotic, bile spillage, and postoperative wound infection were entered in predesigned proforma. Microsoft Excel was used to analyze the data. RESULTS: In total, 310 patients were eligible for analysis, 154 in GrAP and 156 in GrAPn. Both groups were comparable in patient demographic and clinical characteristics such as average age (40.3 vs. 41.6 years) and sex (female 77.6% vs. 78.6%). Overall wound infection occurred in 4.8% (15/310). There was no significant difference in wound infections among the two groups (p = 0.442): GrAP 3.9% and GrAPn 5.8%. There was no mortality in this series. CONCLUSION: Routine preoperative antibiotic prophylaxis is not necessary in low-risk symptomatic gallstonepatients undergoing laparoscopic cholecystectomy.