Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 622
- 试验地点
- 8
- 主要终点
- Incisional surgical site infection (SSI) rate
研究概览
简要总结
The purpose of the study is to determine if short-term outcomes of rectal resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to rectal resections with only mechanical bowel preparation.
详细描述
The design involves random allocation of eligible patients to full bowel preparation or only mechanical bowel preparation in 1:1 ratio. After that rectal 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 surgical site infection is anticipated to decrease from 12% (data from local registry) to 6%. For power of 80% enrolment of 622 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 rectum or rectosigmoid junction
- •clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
- •indications for surgical rectal 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 obstructive resection or abdominoperineal excision
- •Acute bowel obstruction, bleeding or perforation
- •Other malignancies not in remission
结局指标
主要结局
Incisional surgical site infection (SSI) rate
时间窗: 30 days
Rate of incisional SSI in patients after rectal resections
次要结局
- Anastomotic leak rate(30 days)
- Intraabdominal and or pelvic abscess rate(30 days)
- Surgery duration in minutes(Duration of surgical procedure)
- Rate of intraoperative complications(Duration of surgical procedure)
- Overall morbidity(30 days)
- Quality of bowel preparation assessed by surgeon(Day of surgery)
- Bowel preparation compliance(Day of surgery)