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NOT YET RECRUITING
NCT06510452
NA

Antibiotic Prophylaxis in Metabolic Bariatric Surgery

Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

3352

Start Date

2024-10-01

Completion Date

2026-04-01

Last Updated

2024-07-31

Healthy Volunteers

Yes

Interventions

DRUG

2000 mg of Cefazolin

receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.

DRUG

500 mg of Metronidazole IV

receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.

DRUG

NACL 0.9% 100 ml

receive 100 ml NACL0.9% without any antibiotics in it.

Locations (2)

Madina Women's Hospital

Alexandria, Egypt

WeightWorks clinics

Amersfoort, Utrecht, Netherlands