Abstract
Objectives:
Evaluation of role of prophylactic antibiotic in preventing the post operative infective complications in low risk patients patients undergoing elective laparoscopic cholecystectomy.
Methods:
This randomized clinical trial, conducted from June 2016 to April 2018 at tertiary care teaching hospital in northern India, included 100 patients ( 50 patients in Group A: prophylactic antibiotic group with cefuroxime 1.5 gm IV and 50 in Group B: no antibiotic group. Symptomatic low risk cholelithiasis patients of American Society of Anesthesiologist (ASA) 1 and 2 without comorbidities were included. Patients younger than 18 years, antibiotic consumption seven days before laparoscopic cholecystectomy , immune compromised patients, history of acute cholecystitis within 6 weeks prior to admission, obstructive jaundice, gallstone pancreatitis, previous biliary tract surgery, evidence of cholangitis / biliary stent in situ, post ERCP, diabetes mellitus, conversion to open, chronic obstructive pulmonary disease (COPD), ASA grade 3 or more and those not consenting for participation in study were excluded. These patients were followed up in OPD for next one month on weekly basis especially for any evidence of surgical site infections. The following data were collected for each patient: age, gender, body weight, ASA score, intra operative gallbladder perforation with bile leak and/or stones spillage, duration of surgery and type of infective complications and its treatment. At the end of study, data was collected and recorded in individual proforma and analyzed by using Student t-test and Chi-square test. We assumed statistically a significant difference at P< 0.05.

Results:
In total, 100 patients were analysed , 50 in antibiotic group and 50 in no antibiotic group. Both groups were comparable in patient demographic and clinical characteristics such as mean age in group A patients was 46.46+13.78(SD) years and in group B was 43.78 +14.83(SD) years. In group A,43/50 (86%) of the patients were female while in group B,40/50 (80%) of the patients were female. Intraoperative biliary spillage was encountered in 46 patients, 32 in Group A and 14 in Group B(P <.01 ). Average time of surgery was also comparable in both groups 73.70 vs 65.71 sec ,p=0.351. The overall rate of postoperative infective complications was one out of 100 (1%) patients.There was no mortality in this series.
Conclusion:
Routine preoperative antibiotic prophylaxis is not necessary in low-risk symptomatic gallstone patients undergoing laparoscopic cholecystectomy. We recommend high volume, multi institutional clinical trials with less restricted inclusion criteria.

Key words: Gallbladder perforation, Laparoscopic cholecystectomy, Prophylactic antibiotics.