Single- Versus Multiple-dose Antimicrobial Prophylaxis for The Prevention of Infectious Complications Associated With Peroral Endoscopic Myotomy(POEM) for Achalasia: A Triple-Blind, Randomized Controlled, Non-Inferiority Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 666
- 试验地点
- 1
- 主要终点
- Infectious complications associated with POEM
研究概览
简要总结
Peroral endoscopic myotomy is a novel, promising endoscopic technique for achalasia considering its minimal invasive characteristics and comparable efficacy to Heller myotomy. Numerous studies have focused on the efficacy, safety as well as technical aspects of POEM. However, few efforts have been made to the issue of antimicrobial prophylaxis in POEM. Postoperative prophylactic antibiotics are universally initiated on call to the operating room or at the start of POEM and consist of second-generation cephalosporins. The mean duration of antibiotic regimen after POEM was 3 days ranging from 1 day to 7 days.
Numerous studies have shown that a single dose of antibiotic prophylaxis in a variety of surgical procedures. Other studies have shown that prolonged administration of antibiotics for longer than 24 hours add no benefit in many surgeries. 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.
Thus, investigators intend to perform a prospective randomized study to confirm the validity of single-dose antimicrobial prophylaxis for the prevention of infectious complications following peroral endoscopic myotomy.
详细描述
This prospective randomized trial is performed to confirm the noninferiority of single-dose versus multiple-dose antimicrobial prophylaxis in terms of the incidence of infectious complications associated with peroral endoscopic myotomy. Six hundred sixty-six patients undergoing POEM for achalasia will be randomized to receive only single-dose ceftazidime (2g) or an additional 2 doses every 12 hours postoperatively (multi-dose group). POEM associated infectious complications will be assessed and recorded as regional infections, remote infections and systemic infections. Infection rate, adverse events related to antibiotics and POEM, Clavien-Dindo classification of surgical complications, length of hospital stay and efficacy of POEM will be compared. Body fluid bacterial culture will be conducted in patients suspected of infectious complications.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Sequentially numbered, opaque sealed envelopes(SNOSE) will be the method to conceal allocation from the study team.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed of esophageal achalasia
- •Patients or legal surrogates willing and competent to give informed consent and to comply with follow up visits and tests
排除标准
- •Patients with ASA score ≥3
- •Patients with indications for antibiotic prophylaxis(infective endocarditis or other conditions) as determined by the American Society for Gastrointestinal Endoscopy
- •Patients who have received antibiotics in the past seven days
- •Patients who have possible signs of infection during preparation for POEM
- •Immunodeficient patients such as severe neutropenia(<0.5x1068/l) and/or advanced hematological malignancy
- •Under steroid therapy
- •Patients who develop intraoperative severe adverse events including severe choking and aspiration during endotracheal intubation requiring antibiotic treatment as well as severe pneumothorax, perforation, bleeding and mucosal injury cannot be closed by clips.
研究组 & 干预措施
Single-dose group
Ceftazidime 2g at the start of POEM
干预措施: Saline Solution (Drug)
Multiple-dose group
Ceftazidime 2g at the start of POEM plus additional 2 doses given every 12 hours after the procedure
干预措施: Ceftazidime (Drug)
结局指标
主要结局
Infectious complications associated with POEM
时间窗: From operation day to 4 weeks after the procedure
Including regional, remote and systemic infections.
次要结局
- Adverse effects of antibiotics(From operation day to 4 weeks after the procedure)
- Pathogens for causing infection(From operation day to 4 weeks after the procedure)
- Clavien-Dindo classification of surgical complications(From operation day to 4 weeks after the procedure)
- Length of hospital stay(From admission to discharge)
- Efficacy of POEM(admission to 4 weeks after POEM)