Pinar Sarkut1, Sadik Kilicturgay2, Hikmet Aktas3, Yilmaz Ozen1, Ekrem Kaya1. 1. 1 Department of General Surgery, Uludag University , Bursa, Turkey . 2. 2 Department of General Surgery, Medical Park International Hospital , Bursa, Turkey . 3. 3 Department of General Surgery, Acibadem International Hospital , Bursa, Turkey .
Abstract
BACKGROUND:Laparoscopic cholecystectomy (LC) is the gold standard for the treatment of symptomatic gallbladder stones. As infections are rare in uncomplicated LC, it is widely accepted that prophylactic antibiotics need not be administered, and guidelines do not support routine antibiotic prophylaxis during elective LC. However, routine antibiotic prophylaxis for elective LC is still popular in many clinical settings. We investigated this situation in our department. METHOD: This randomized double-blind controlled study included 570 patients who underwent LC between March 2007 and February 2010. The exclusion criteria were antibiotic intake before surgery, steroid treatment, and the presence of pancreatitis, cholangitis, obstructive jaundice, cephalosporin allergy, or pregnancy. The patients were randomized into three groups. Group 1 (n = 193) received physiologic saline as placebo, Group 2 (n = 191) received a first-generation cephalosporin (cefazolin; 1 g), and Group 3 (n = 186) received a second-generation cephalosporin (cefuroksim aksetil; 750 mg). Bile and epigastric and umbilical port tissue samples were harvested for culture. All patients were observed until the end of the fourth week after surgery. Patient age, sex, weight, American Society of Anesthesiologists (ASA) score, diabetes mellitus, smoking history, history of biliary colic in the past month, length of the hospital stay before the operation, operational findings (acute or chronic cholecystitis), operation duration, use of drainage, type of prophylaxis administered if any, culture results, surgical site infection (SSI) development, and time to SSI development along with associated treatments were evaluated. RESULTS: There was no statistically significant difference between the groups with respect to any of the demographic and clinical features analyzed in this study. The SSI rate was 1.2% in total, and in Groups 1, 2, and 3, it was 1.5%, 1.04%, and 1.07%, respectively. There was no statistical difference regarding SSI among the groups (p = 1.00). Superficial SSI was observed in all groups, and in all patients, the site of infection was the entrance to the epigastric port through which the gallbladder had been removed. CONCLUSIONS: Surgical site infection is rare after LC, and antibiotic prophylaxis does not appear to affect the outcome significantly. Moreover, factors such as positive bile cultures, history of biliary attack, ASA score, diabetes, obesity, and smoking do not have any effect on SSI development. Thus, we conclude that antibiotic prophylaxis is not needed for elective LC.
RCT Entities:
BACKGROUND: Laparoscopic cholecystectomy (LC) is the gold standard for the treatment of symptomatic gallbladder stones. As infections are rare in uncomplicated LC, it is widely accepted that prophylactic antibiotics need not be administered, and guidelines do not support routine antibiotic prophylaxis during elective LC. However, routine antibiotic prophylaxis for elective LC is still popular in many clinical settings. We investigated this situation in our department. METHOD: This randomized double-blind controlled study included 570 patients who underwent LC between March 2007 and February 2010. The exclusion criteria were antibiotic intake before surgery, steroid treatment, and the presence of pancreatitis, cholangitis, obstructive jaundice, cephalosporinallergy, or pregnancy. The patients were randomized into three groups. Group 1 (n = 193) received physiologic saline as placebo, Group 2 (n = 191) received a first-generation cephalosporin (cefazolin; 1 g), and Group 3 (n = 186) received a second-generation cephalosporin (cefuroksim aksetil; 750 mg). Bile and epigastric and umbilical port tissue samples were harvested for culture. All patients were observed until the end of the fourth week after surgery. Patient age, sex, weight, American Society of Anesthesiologists (ASA) score, diabetes mellitus, smoking history, history of biliary colic in the past month, length of the hospital stay before the operation, operational findings (acute or chronic cholecystitis), operation duration, use of drainage, type of prophylaxis administered if any, culture results, surgical site infection (SSI) development, and time to SSI development along with associated treatments were evaluated. RESULTS: There was no statistically significant difference between the groups with respect to any of the demographic and clinical features analyzed in this study. The SSI rate was 1.2% in total, and in Groups 1, 2, and 3, it was 1.5%, 1.04%, and 1.07%, respectively. There was no statistical difference regarding SSI among the groups (p = 1.00). Superficial SSI was observed in all groups, and in all patients, the site of infection was the entrance to the epigastric port through which the gallbladder had been removed. CONCLUSIONS: Surgical site infection is rare after LC, and antibiotic prophylaxis does not appear to affect the outcome significantly. Moreover, factors such as positive bile cultures, history of biliary attack, ASA score, diabetes, obesity, and smoking do not have any effect on SSI development. Thus, we conclude that antibiotic prophylaxis is not needed for elective LC.
Entities:
Keywords:
laparoscopic cholecystectomy; prophylactic antibiotics; surgical site infection