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ClinicalTrials.gov ID

NCT06510452

Lead Sponsor

General Committee of Teaching Hospitals and Institutes, EgyptOTHER_GOV

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

3,352Estimated

Last Update Posted

Jul 31, 2024Actual

Start Date

Oct 1, 2024Estimated

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Apr 1, 2026Estimated

Official Title

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

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.

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

• 2000 mg of Cefazolin
• 500 mg of Metronidazole IV
• NACL 0.9% 100 ml

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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.

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

General Committee of Teaching Hospitals and Institutes, EgyptOTHER_GOV

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