Prophylactic antibiotic versus no antibiotic in patients undergoing elective laparoscopic cholecystectomy: a randomized controlled trial

Antibiotics should be used judiciously to prevent the development of antibiotics resistance, adverse effects as well to reduce the cost of treatment. There is great need for a more stringent and uniform use of antibiotics prophylaxis in general surgery. This study is aimed to compare the incidence of surgical site infections in patients undergoing elective laparoscopic cholecystectomy with prophylactic antibiotic and no antibiotic. This is a randomized controlled study to be carried out in the Department of Surgery, RIMS, Imphal. The duration of the study will be of around 02 years from July 2024 to June 2026. A total of 172 patients admitted in Department of surgery, RIMS, Imphal for undergoing laparoscopic cholecystectomy would be included as governed by inclusion/exclusion criteria. 86 patients will be allocated randomly to either group (with prophylactic antibiotic or no antibiotic group) using computer generated random tables. After obtaining ethical clearance, informed consent will be taken from the patients after explaining the nature and purpose of the study being done. Participants will be blinded. The patients will be subjected to a detailed pre-operative, intra-operative and post operative assessment. Patients would be followed up for a period of 30 days after surgery and observations will be noted. Surgical site infections if any will be treated and patient will be followed up till SSI resolves. After the study period, data will be analysed for statistical significance. The findings of this randomized controlled trial will be tabulated graphically. Descriptive statistics will be used for data analysis.

There is no such study done in this region (North Eastern part of India) in the past which compares the incidence of surgical site infections in elective laparoscopic cholecystectomy with prophylactic antibiotic versus without antibiotic hence my study will help in addressing the research gap and contribute valuable insights to the existing literature.