Antibiotic Prophylaxis in Metabolic Bariatric Surgery

Launched by GENERAL COMMITTEE OF TEACHING HOSPITALS AND INSTITUTES, EGYPT · Jul 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether patients undergoing Metabolic Bariatric Surgery (MBS) can safely skip antibiotic treatment before their surgery without increasing the risk of infections. Normally, antibiotics are given to help prevent infections at the surgical site, but since these infections are quite rare in laparoscopic surgeries like MBS, researchers want to see if not using antibiotics might be just as safe. The trial will compare two groups: one group will not receive antibiotics, while the other will receive the standard antibiotic treatment before surgery. Researchers will then check for any infections that occur within six weeks after the surgery.

To be eligible for this trial, participants must be adults over 18 who are approved for MBS based on specific guidelines. However, certain individuals, such as those with severe allergies to antibiotics, active infections, or other serious health conditions, will not be able to participate. If you join the trial, you'll be randomly assigned to one of the two groups, and you'll be monitored closely after your surgery to ensure your safety and health. This study is important because it may help determine if antibiotics are truly necessary in this type of surgery, potentially leading to better treatment practices in the future.

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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.