Antibiotic Prophylaxis in Metabolic Bariatric Surgery
Status:
NOT_YET_RECRUITING
Trial end date:
2026-04-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
NA
Details
Lead Sponsor:
General Committee of Teaching Hospitals and Institutes, Egypt