Randomized Control Study Comparing Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Infectious complications associated with POEM
研究概览
简要总结
Achalasia cardia is a primary oesophageal motility disorder of unknown etiology. Recently, peroral endoscopic myotomy (POEM) has gained widespread acceptance as an effective treatment modality for achalasia.
Major adverse events are uncommon with POEM. Since the operator works close to mediastinum during the POEM procedure, there is a potential for infectious complications. Therefore, intravenous antibiotics are universally used to prevent infection-related adverse events. There is no fixed protocol or duration of antibiotics for the same.
详细描述
POEM is a novel minimally invasive treatment for achalasia, which emerged as an offshoot of natural orifice transluminal endoscopic surgery (NOTES). Major adverse events during POEM are rare and therefore, the procedure is considered safe.
Bacteremia can occur after endoscopic procedures like esophageal dilation, sclerotherapy of varices, and instrumentation of obstructed bile ducts. Bacteremia has been advocated as a surrogate marker for risk of infection-related complications. In POEM procedure, the endoscopist works in close proximity to mediastinum and peritoneal cavity. Therefore, the potential for infection-related complications is high. However, despite of different antibiotic protocols at different centers, the reported incidence of infection-related complications is very low. At present, prophylactic antibiotics are universally initiated before starting the POEM procedure and continued for a variable duration after POEM ranging from 1 day to 7 days.
Data from surgical studies indicate that prolonged administration of antibiotics for longer than 24 hours may not be beneficial. Prolonged use of antibiotics not only increases the costs and exposure to drug toxicity directly but also may be associated with an increased risk of acquired antibiotic resistance as well as infection with Clostridium difficile.
With this background, we planned a study to evaluate the difference in the infectious complications between short vs long duration antibiotic in patients with achalasia undergoing POEM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the patient(aged 18-65) who underwent POEM for achalasia cardia.
排除标准
- •Unwillingness to give written informed consent
- •Patients with multiple co morbidities.
- •Immunocompromised patients /on steroid therapy.
- •Patients with indications for antibiotic prophylaxis (infective endocarditis).
- •Patients who have received antibiotics in the last 1 week .
- •Patients who have possible signs of infection during preparation for POEM
研究组 & 干预措施
First group
This group will receive an intravenous antibiotic for three days. The first dose will be given within half hour before the POEM procedure.
干预措施: One dose of Cefo-perazone Sulbactum (Drug)
Second group
This group will receive only one dose of intravenous antibiotic within half hour before the POEM procedure
干预措施: One dose of Cefo-perazone Sulbactum (Drug)
结局指标
主要结局
Infectious complications associated with POEM
时间窗: 1 month
The primary outcome of the study is to estimate the difference in the incidence of infectious complications in the two groups
次要结局
- Comparison of serum Procalcitonin between the two groups(72 hours)
- Comparison of erythrocyte sedimentation rate (ESR) between the two groups(72 hours)
- Incidence of positive blood cultures(72 hours)
- Adverse events associated with administration of intravenous antibiotics(1-month)
- Comparison of inflammatory markers (CRP) between the two groups(72 hours)
研究者
Mohan Ramchandani
Consultant Gastroenterologist
Asian Institute of Gastroenterology, India