Status:

NOT_YET_RECRUITING

Antibiotic Prophylaxis in Metabolic Bariatric Surgery

Lead Sponsor:

General Committee of Teaching Hospitals and Institutes, Egypt

Conditions:

Antibiotic Reaction

Wound Infection Superficial

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief Summary

SUMMARY Rationale: Prophylactic antibiotics in laparoscopic surgeries, including Metabolic Bariatric Surgery (MBS), are routinely provided to reduce postoperative infections, especially at wound incis...

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 resource...

Eligibility Criteria

Inclusion

  • ° 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

  • 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.

Key Trial Info

Start Date :

October 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2026

Estimated Enrollment :

3352 Patients enrolled

Trial Details

Trial ID

NCT06510452

Start Date

October 1 2024

End Date

April 1 2026

Last Update

July 31 2024

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Madina Women's Hospital

Alexandria, Egypt, 21531

2

WeightWorks clinics

Amersfoort, Utrecht, Netherlands

Antibiotic Prophylaxis in Metabolic Bariatric Surgery | DecenTrialz