Mechanical Bowel Preparation Versus no Bowel Preparation for Esophageal Cancer Surgery: a Multi-center, Randomized, Parallel, Single-blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 652
- 试验地点
- 1
- 主要终点
- the rate of major complications
研究概览
简要总结
The study type was designed as a prospective multicenter randomized controlled study. The patients will be divided into intervention group and control group, 281 patients were needed for each group and 562 patients would be needed totally to show this difference. Due to a possible loss of 14%, the final sample size was calculated to be 652 patients. The intervention group will not implement mechanical bowel preparation(MBP) before surgery; the control group will receive routine preoperative MBP for oral administration of compound polyethylene glycol electrolyte powder and fasting water. Perioperative complications, intestinal recovery speed and quality of life will be investigated between the two groups.
详细描述
Patients allocated to MBP will be instructed by the study nurse to prepare their bowel mechanically by drinking 3~4L of polyethylene glycol (Polyethylene Glycol Electrolytes Powder 68.56g; Shenzhen, China) with water before 6pm in the evening the day before the surgery. Patients allocated to NBP were instructed to not prepare the bowel. The receipt of the allocated intervention will be controlled by study nurse asking the patients on the morning of the surgery whether they had acted as instructed by the allocation. This information will be also concealed from treating physicians and surgeons, data collectors, and data analysts, until the primary and secondary outcomes were analyzed. All patients will follow the ERAS protocol. Prophylactic intravenous antibiotics (cephamycin 1000mg) will be given to all patients 30 minutes before skin incision. The prophylactic intravenous antibiotics will re-administered if the surgery lasted longer than 3h from the first antibiotic dose. Surgical skin preparation will involve taking a bath well the night before operation without shaving the hair. Just before skin incision, the area will then washed three times with denatured 80% alcohol to left to dry.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were scheduled for esophageal cancer resection in participating centers were eligible for inclusion.
排除标准
- •need for emergency surgery;
- •previous chronic constipation or diarrhea;
- •previous abdominal surgery; need for colonic reconstruction;
- •other indications for mechanical preparation or contraindications;
- •allergy to drugs used in the trial (polyethylene glycol)
结局指标
主要结局
the rate of major complications
时间窗: during surgery orwithin 30 days after surgery
A major intraoperative and postoperative complication was defined as a surgical or medical complication with a Clavien-Dindo (CD) grade of Ⅱor higher (this five-grade system includes sub-grades in grades Ⅲ and Ⅳ, and higher grades indicate more life-threatening complications) according to Esophagectomy Complications Consensus Group (ECCG)
次要结局
未报告次要终点