Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Resections for Cancer Versus no Bowel Preparation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 586
- 试验地点
- 2
- 主要终点
- Anastomotic leak rate
研究概览
简要总结
The purpose of the study is to determine if short-term outcomes of colon resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to colon resections with no bowel preparation.
详细描述
The design involves random allocation of eligible patients to full bowel preparation or no bowel preparation in 1:1 ratio. After that colon resection is performed in both groups.
Short-term outcomes are assessed in 30 day period after surgery. This is a superiority trial evaluating statistical superiority. Rate of anastomotic leak is anticipated to decrease from 8% (data from local registry) to 3%. For power of 80% enrolment of 586 patients is required.
The intent-to-treat principle is used for the data analysis.
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
- None
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
- •histologically confirmed adenocarcinoma of the colon (caecum, ascending, transverse, descending, sigmoid)
- •clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
- •indications for surgical colonic resection
- •ECOG status 0-2
- •At least 18 years of age
- •Written informed consent
排除标准
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
- •Pregnancy or breast feeding
- •Medical contraindications for surgical treatment
- •Any use of antibiotics 30 days prior to inclusion
- •Functioning stoma
- •Contraindications for use of MBP or OA drugs or their components
- •Indications for mandatory MBP (planned intraoperative colonoscopy etc)
- •Indications for obstructive resection
- •Acute bowel obstruction, bleeding or perforation
- •Other malignancies not in remission
结局指标
主要结局
Anastomotic leak rate
时间窗: 30 days
Rate of anastomotic leak in patients after colon resections
次要结局
- Intraabdominal and or pelvic abscess rate(30 days)
- Rate of intraoperative complications(Duration of surgical procedure)
- Quality of bowel preparation assessed by surgeon(Day of surgical procedure)
- Surgical site infection (SSI) rate(30 days)
- Overall morbidity(30 days)
- Surgery duration in minutes(Duration of surgical procedure)
- Bowel preparation compliance(Day of surgical procedure)