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A Prospective Randomized Study

Adriano Tocchi, MD; Luca Lepre, MD, PhD; Gianluca Costa, MD, PhD; Gianluca Liotta, MD; Gianluca Mazzoni, MD; Fabrizio Maggiolini, MD

Arch Surg. 2000;135:67-70.

Hypothesis  The need for antibiotic treatment when performing elective laparoscopic cholecystectomy may not be as important as it is thought. This study assesses the real efficacy of antibiotic prophylaxis in elective laparoscopic cholecystectomy with respect to the postoperative infection rate.

Design  A prospective randomized study on the routine use of antibiotic prophylaxis in laparoscopic cholecystectomy.

Setting  University teaching hospital, La Sapienza, Italy.

Patients  Eighty-four patients randomly placed into 2 groups (A [n = 44] and B [n = 40]) immediately before undergoing laparoscopic cholecystectomy.

Methods  Before anesthesia was administered, group A received intravenously 2 g of cefotaxime sodium diluted in 100 mL of isotonic sodium chloride solution; group B, 10 mL of isotonic sodium chloride solution in 100 mL of saline. A gallbladder bile sample for culture was withdrawn intraoperatively from all patients. In both groups, age, sex, weight, duration of surgery, presence of diabetes, American Society of Anesthesiologists patient classification score, preoperative autologous blood donation, antibiotic administration, intraoperative gallbladder rupture, findings from bile culture positive for bacteria, episodes of colic within 30 days before surgery, length of postoperative hospital stay, and number of septic complications were recorded. All data were correlated by univariate and multivariate analyses with the onset of septic phenomena.

Results  In group A, 3 cases of wound infection, 1 case of subhepatic abscess from bile leakage, and 1 case of urinary tract infection were observed; group B, 4 cases of wound infection, 1 case of bronchopneumonia, and 2 cases of urinary tract infection. Comparison of data showed no statistically significant difference between the groups. Findings from bile examination in patients with sepsis complications were positive in 5 patients in group A and in 6 in group B (P = .91). Multivariate analysis showed diabetes mellitus and colic episodes within 30 days before surgery as independent factors significantly associated to the onset of infectious complications.

Conclusions  In elective laparoscopic cholecystectomy, antibiotic treatment did not seem to affect the incidence and severity of infections or the degree of bile contamination.

From the First Department of Surgery, University of Rome, La Sapienza, Italy.

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