Prospective Randomized Monocentric Trial of Mechanical Bowel Preparation Alone vs Mechanical Bowel Preparation Combined With Oral Antibiotics Before Colorectal Resections for Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Surgical Site Infections
研究概览
简要总结
Investigation of the role of adding oral antibiotics to preoperative mechanical bowel preparation before colorectal surgery for cancer.
详细描述
The aim of the study is to investigate whether the addition of oral antibiotics to Mechanical Bowel Preparation (MBP) prior to colorectal cancer surgical procedures reduce the superfical and deep surgical site (SSI) infectious complications. The study is prospective and is designed in a randomized single-blinded controlled fashion. It is taking place at one academic surgical unit of Athens Medical School, located at a tertiary referal institution. Patients scheduled to undergo an elective surgical resection for colon or rectal cancer will be allocated to either formal MBP the day before surgery or a combined MBP with administration of oral antibiotics. Exclusion criteria are the following: emergency surgery, obstructive or perforated cancer, patients intolerance to bowel preparation regimen and allergies to orally administered antibiotics.
Intervention arms: Patients will be randomised into two groups, concealed from the treating surgeon.
Group A:
Preoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with MBP (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)
Group B:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled colorectal cancer surgery
排除标准
- •Emergency surgery
- •Obstructive and perforated cancer
- •Intolerance to bowel preparation regimen
- •Allergies to orally administered antibiotics
研究组 & 干预措施
Bowel Preparation plus antibiotics
Preoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)
干预措施: Bowel Preparation plus antibiotics (Other)
Bowel Preparation
Preoperative mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)
干预措施: Bowel Preparation (Other)
结局指标
主要结局
Surgical Site Infections
时间窗: 30 days
Surgical Site Infections
次要结局
- Patients' preparation tolerance(30 days)
- Readmission rate(30 days)
- Other surgical and non-surgical compliactions(30 days)
- Anastomotic leaks(30 days)
- Preparation regimens side-effects(30 days)
- Hospital length of stay(30 days)
- Time to beginning of adjuvant treatment for colorectal cancer(60 days)
研究者
George Theodoropoulos
Associate Professor
National and Kapodistrian University of Athens