SUMMARY Rationale: Prophylactic antibiotics in laparoscopic surgeries, including Metabolic Bariatric Surgery (MBS), are routinely provided to reduce postoperative infections, especially at wound incision sites. However, since incisional wound infections in laparoscopic MBS are rare and morbidity is very low, the benefit of antibiotic prophylaxis is questionable.
Objective: Evaluate the non-inferiority of omitting antibiotic prophylaxis in MBS. Compare postoperative outcomes between Group A (no antibiotics) and Group B (standard antibiotic care) to determine if omission increases complications, particularly wound infections.
Study Design: Randomized controlled trial (RCT), double-blind.
Study Population: Patients with obesity eligible for MBS.
Intervention:
* Group A (No Antibiotic Prophylaxis): Undergo MBS without antibiotics to test safety regarding postoperative complications, focusing on surgical site infections (SSIs). * Group B (Standard Antibiotic Prophylaxis): Receive standard one-time antibiotics before incision.
Main Study Parameters/Endpoints: Compare the incidence of incisional and organ/space SSIs within six weeks post-surgery between Group A and Group B to determine if omitting antibiotics affects infection rates.
None
Patients undergoing immunotherapy or corticosteroid treatment for Crohn's disease or rheumatoid arthritis.
Patients with a history of endocarditis require prophylactic antibiotics.
Patients with known severe allergies to antibiotics.
Patients with active infections or recently treated with antibiotics (within the last 30 days).
Parallel
2000 mg of Cefazolin
Drugreceive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.
500 mg of Metronidazole IV
Drugreceive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.
NACL 0.9% 100 ml
Drugreceive 100 ml NACL0.9% without any antibiotics in it.
Comparison of incidence of postoperative wound infections in both treatment arms
Aims to evaluate the non-inferiority of foregoing antibiotic prophylaxis in MBS. The study will compare postoperative outcomes between two groups: Group A, which will not receive antibiotic prophylaxis, and Group B, which will receive standard care including a one-time administration of antibiotics, to test the hypothesis that omitting antibiotic prophylaxis does not significantly increase the incidence of postoperative complications, in particular wound infections.
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