Antibiotic Prophylaxis in Metabolic Bariatric Surgery

July 29, 2024 updated by: Mohamed Hany Ashour, General Committee of Teaching Hospitals and Institutes, Egypt

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

3352

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21531
        • Madina Women's Hospital
  • Netherlands
    • Utrecht
      • Amersfoort, Utrecht, Netherlands
        • WeightWorks Clinics
        • Contact:
        • Contact:
        • Principal Investigator:
          • Edo Aarts, MD/PhD
        • Sub-Investigator:
          • Frits Berends, MD/PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NACL0.9%
Group A will receive 100 ml NACL0.9% without any antibiotics in it.
Drug: NACL 0.9% 100 ml
receive 100 ml NACL0.9% without any antibiotics in it.
Other Names:
  • Saline
Active Comparator: Cefazolin +Metronidazole
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.
Drug: 2000 mg of Cefazolin
receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.
Other Names:
  • Kefzol
Drug: 500 mg of Metronidazole IV
receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.
Other Names:
  • Flagyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of incidence of postoperative wound infections in both treatment arms
Time Frame: 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.
until 6 weeks post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

July 15, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB-BAR-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The analysis will be performed on a blinded dataset after the completion of the medical/scientific review. All protocol violations will be identified and resolved, and the dataset will be declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com) and handled according to Good Clinical Practice guidelines, Data Protection Directive certificate, and complied with Title 21 CFR Part 11. Furthermore, the data centers, where all the research data were stored, are certified according to ISO27001, ISO9001, and Dutch NEN7510.

IPD Sharing Time Frame

After the study been peer-reviewed for 20 years available.

IPD Sharing Access Criteria

contact the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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