Clinical trial NCT06510452: Antibiotic Prophylaxis in Metabolic Bariatric Surgery
Official title: Efficacy of Antibiotic Prophylaxis in Metabolic Bariatric Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Antibiotic Reaction
Wound Infection Superficial
Wound Infection Deep
Bariatric Surgery Candidate
Complication,Postoperative
Keywords: anti-biotics
non-inferiority
surgical side infection
Lead sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Sponsor class: OTHER_GOV
First posted: 2024-07-19
Enrollment: 3352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 outcomes:
measure: Comparison of incidence of postoperative wound infections in both treatment arms
timeFrame: until 6 weeks post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Madina Women's Hospital
city: Amersfoort
country: Netherlands
facility: WeightWorks clinics
state: Utrecht
Study officials:
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