Antibiotic Prophylaxis in Metabolic Bariatric Surgery

Not Applicable

Not yet recruiting

• Conditions: Antibiotic Reaction; Wound Infection Superficial; Wound Infection Deep; Bariatric Surgery Candidate; Complication,Postoperative
• Interventions: Drug: NACL 0.9% 100 ml; Drug: 2000 mg of Cefazolin; Drug: 500 mg of Metronidazole IV

• Registration Number: NCT06510452
• Lead Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt

Brief 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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-19
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31
• Study Start: 2024-10-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3352

Inclusion Criteria

° Patients must be older than 18 and meet the eligibility criteria for MBS as outlined by the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) and the Dutch Federation of Medical Specialists for the surgical treatment of obesity.

Exclusion Criteria

• 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).
• Patients with compromised immune systems, including those with HIV/AIDS or undergoing chemotherapy.
• Patients with chronic liver or kidney disease.
• Patients with uncontrolled diabetes (HbA1c > 9%).
• Patients with a history of previous metabolic bariatric surgery.
• Pregnant or breastfeeding women.
• Patients with any other medical condition that, in the opinion of the investigator, would compromise the patient's safety or the study's integrity.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NACL0.9%	NACL 0.9% 100 ml	Group A will receive 100 ml NACL0.9% without any antibiotics in it.
Cefazolin +Metronidazole	2000 mg of Cefazolin	Group B will receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%. Both antibiotics will be administered at least 30 minutes before surgery to ensure adequate tissue concentrations at the time of incision.
Cefazolin +Metronidazole	500 mg of Metronidazole IV	Group B will receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%. Both antibiotics will be administered at least 30 minutes before surgery to ensure adequate tissue concentrations at the time of incision.

Primary Outcome Measures

Name	Time	Method
Comparison of incidence of postoperative wound infections in both treatment arms	until 6 weeks post operative	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.

Trial Locations

Locations (2)

WeightWorks clinics; 🇳🇱 Amersfoort, Utrecht, Netherlands

Madina Women's Hospital; 🇪🇬 Alexandria, Egypt