Impact of Antibiotic Prophylaxis and Conditioning Modalities in Per Oral Endoscopic Myotomy for Esophageal Motor Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 252
- 主要终点
- The occurence of postoperative complications, according to Cotton's classification
研究概览
简要总结
No recommendation regarding antibiotic prophylaxis and preparation modalities are available for patients with esophageal motor disorders who benefit from Per-Oral Endoscopic Myotomy (POEM). The aim of our study was to evaluate the impact of antibiotic prophylaxis on the POEM's safety.
This study was a comparative and multicentric retrospective analysis of a database prospectively maintained. Patients over 18 year's old with esophageal motor disorders confirmed by prior manometry, who underwent POEM were included. The primary endpoint was the occurrence of complications, as classified by Cotton, based on whether or not antibiotic prophylaxis was administered.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patients presenting a major esophageal motor disorder confirmed by prior manometry according to the Chicago classification and treated by per-oral endoscopic myotomy after a multidisciplinary meeting decision
排除标准
- •Under-age patients were excluded
研究组 & 干预措施
POEM + Antibiotic prophylaxis
Cefazolin: 2g or Amoxicillin - clavulanic acid: 1g x 3 during 7 days
干预措施: Antibiotics (Drug)
结局指标
主要结局
The occurence of postoperative complications, according to Cotton's classification
时间窗: 7 Days
Depending on whether or not antibiotic prophylaxis was administered
次要结局
- The evaluation of the efficacy of the procedure(1 Month)
- The occurence of perioperative and postoperative complications(7 Days)
- The C-Reactive Protein and white blood cells count sampled(1 Day)
研究者
VANBIERVLIET
Medical Doctor,Physician Doctor, Principal Investigator
Société Française d'Endoscopie Digestive