Efficacy of Antibiotic Prophylaxis in Metabolic Bariatric Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,352
- 试验地点
- 2
- 主要终点
- Comparison of incidence of postoperative wound infections in both treatment arms
研究概览
简要总结
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.
详细描述
Nature and Extent of the Burden and Risks:
Rationale:
- Cost-Effectiveness: Reducing antibiotic use could lower surgical costs.
- Resource Utilization: Simplifying protocols save hospital resources.
- Antibiotic Resistance: Reducing use helps combat resistant bacteria.
- Adverse Reactions: Fewer antibiotics may reduce side effects.
Risk Assessment:
- Increased Infection Rates: Monitor SSI and organ/space SSI rates closely.
- Anastomotic Leaks and Reoperations: Assess the impact on leaks and operations.
- Readmissions and Postoperative Interventions: Evaluate the effect on readmission and intervention rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •° 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.
排除标准
- •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.
研究组 & 干预措施
NACL0.9%
Group A will receive 100 ml NACL0.9% without any antibiotics in it.
干预措施: NACL 0.9% 100 ml (Drug)
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.
干预措施: 2000 mg of Cefazolin (Drug)
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.
干预措施: 500 mg of Metronidazole IV (Drug)
结局指标
主要结局
Comparison of incidence of postoperative wound infections in both treatment arms
时间窗: 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.
次要结局
未报告次要终点
研究者
Mohamed Hany Ashour
head of bariatric surgery
General Committee of Teaching Hospitals and Institutes, Egypt