title: The Effect of Prophylactic Antibiotics on Post Laparoscopic Cholecystectomy Infectious Complications: A Double-Blinded Clinical Trial.
abstract: BACKGROUND
  Laparoscopic cholecystectomy (LC) is one of the most common surgeries in laparoscopic surgery. Although, it is believed that LC has low-risk for post-operative infectious complications, the use of a prophylactic antibiotic is still controversial in elective LC.
  
  
  OBJECTIVE
  To determine the impact of prophylactic antibiotics on postoperative infection complications in elective laparoscopic cholecystectomy.
  
  
  METHODS
  In this double-blind, placebo-controlled, randomized, clinical trial, patients who were candidates for elective LC, from March 2012 to 2015, in four hospitals in Babol, Iran, were studied. Patients were allocated randomly to two groups, i.e., group C: Cefazolin (n = 182) and group P: placebo (n = 247). Group C received 1 g of Cefazolin 30 minutes before anesthesia and and then, six and 12 hours after anesthesia. Group P patients received 10 ml of isotonic sodium chloride solution. Age, gender, type of gallbladder diseases (stone, polyp, or hydrops), the length of post-operative hospitalization, frequency of gallbladder rupture, the duration of surgery, and the kinds of complications associated with infections were collected for each patient in the two groups. The data were analyzed by IBM-SPSS version 20, using the t-test and the chi-squared test, and a p-value < 0.05 was considered as significant.
  
  
  RESULTS
  There were no significant differences between the two groups in terms of gender (C versus P: 18 (9.9%) male versus 22 (9%); p = 0.74), age (C versus P: 43.75 + 13.30 years versus 40.91 + 13.05; p = 0.20), and duration of surgery (C versus P: 34.97 ± 8.25 min versus 34.11 ± 8.39; p = 0.71). There were no significant differences between the two groups in the incidences of post-operative infection (C versus P: 3 (1.7%) versus 5 (2%); p = 0.99) and rupture of the gallbladder (C versus P: 14 (7.8%) versus 17 (6.8%); p = 0.85). No other post-operative systemic infectious complications (e.g., sepsis, pneumonia, or urinary tract infection) were found in either group.
  
  
  CONCLUSIONS
  For patients who underwent laparoscopic cholecystectomy (LC), prophylactic antibiotics had no important role in the prevention of infections; so these antibiotics apparently are not necessary in treatment, and they are not recommended for patients with laparoscopic cholecystectomy as low-risk selective antibiotics.
  
  
  BACKGROUND
  The trial was registered at the Iranian Clinical Trial Registry (http://www.irct.ir) with the IRCT identification number IRCT2013070413865N1.
  
  
  BACKGROUND
  This research was supported financially by the Research Council of Babol University of Medical Sciences.
authors.affiliation: Assistant Professor, Department of Surgery, Clinical Research Development Center, Babol University of Medical Sciences, Babol, Iran.
authors.forename: Ali Asghar
authors.initials: AA
authors.lastname: Darzi
authors.affiliation: Clinical Research Development Center, Shahid Beheshti Hospital, Babol University of Medical Sciences, Babol, Iran.
authors.forename: Alieh
authors.initials: A
authors.lastname: Nikmanesh
authors.affiliation: Assistant Professor, Clinical Research Development Center, Shahid Beheshti Hospital, Babol University of Medical Sciences, Babol, Iran.
authors.forename: Farhad
authors.initials: F
authors.lastname: Bagherian
keywords: Antibiotic prophylaxis; Laparoscopic cholecystectomy; Surgical wound infection