NCT06510452

Antibiotic Prophylaxis in Metabolic Bariatric Surgery

Efficacy of Antibiotic Prophylaxis in Metabolic Bariatric Surgery: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,352 (estimated)
• Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Nature and Extent of the Burden and Risks: Rationale: 1. Cost-Effectiveness: Reducing antibiotic use could lower surgical costs. 2. Resource Utilization: Simplifying protocols save hospital resources. 3. Antibiotic Resistance: Reducing use helps combat resistant bacteria. 4. Adverse Reactions: Fewer antibiotics may reduce side effects. Risk Assessment: 1. Increased Infection Rates: Monitor SSI and organ/space SSI rates closely. 2. Anastomotic Leaks and Reoperations: Assess the impact on leaks and operations. 3. Readmissions and Postoperative Interventions: Evaluate the effect on readmission and intervention rates. Group Relatedness: Comparing groups with and without antibiotics provides evi-dence-based insights into the safety of modifying standard practices to optimize health outcomes and resource use.

Conditions

• Antibiotic Reaction
• Wound Infection Superficial
• Wound Infection Deep
• Bariatric Surgery Candidate
• Complication,Postoperative

Interventions

Type	Name	Description
DRUG	2000 mg of Cefazolin	receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.
DRUG	500 mg of Metronidazole IV	receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.
DRUG	NACL 0.9% 100 ml	receive 100 ml NACL0.9% without any antibiotics in it.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-12-01
• Completion: 2026-04-01
• First posted: 2024-07-19
• Last updated: 2024-07-31

Locations

2 sites across 2 countries: Egypt, Netherlands