Mechanical Bowel Preparation With or Without Oral Antibiotics in Left Sided Colorectal Cancer Surgery: A Randomized Trial (MEBOA Trial)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Surgical Site Infection (SSI)
研究概览
简要总结
In this study, Investigator will compare mechanical bowel preparation with or without oral antibiotics in Left sided colorectal cancer patients undergoing elective surgery.
详细描述
Surgical site infection (SSI) after colorectal surgery is a common postoperative complication, with rates of 15% to 20%, and significantly affects patient morbidity and mortality.
Given the high frequency of SSIs following colorectal procedures and the limited effectiveness of other preventive strategies, the combination of oral antibiotics with mechanical bowel preparation (MBP)-a technique initially evaluated in the 1970s but later discontinued-has regained attention as a potentially effective preventive approach. Recent studies have evaluated the combination of oral antibiotics and mechanical bowel preparation (MBP) with perioperative intravenous antibiotics, showing a significant reduction in the rate of surgical site infections (SSIs).
The Enhanced Recovery After Surgery (ERAS) Society indicates that randomized controlled trials provide some evidence supporting the use of both mechanical bowel preparation and oral antibiotics together, rather than using mechanical bowel preparation alone. American Society of Colon and Rectal Surgeons (ASCRS) Clinical Practice Guidelines also advise the combined use of mechanical bowel preparation and oral antibiotics for patients undergoing elective colorectal surgery. Mechanical bowel preparation before right sided colonic surgery offers no clinical benefit and may lead to preoperative dehydration, electrolyte imbalances, and patient discomfort. However, MBP is beneficial in left sided colorectal rectal surgery.
Despite growing evidence supporting the use of oral antibiotics combined with mechanical bowel preparation (MBP), significant variability in clinical practice persists. In current practice, oral antibiotics are not routinely prescribed for colorectal cancer patients, so this will be interesting to evaluate the effect of oral antibiotics in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This study is double blinded.
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Diagnosed cases of left sided (distal to splenic flexure) colorectal cancer undergoing elective curative sphincter preserving surgery.
- •No contraindication for preoperative administration of oral antibiotics and mechanical bowel preparation.
排除标准
- •Emergency surgery
- •Palliative surgery
- •Unwilling to participate in a trial
研究组 & 干预措施
Mechanical bowel preparation with oral antibiotics
Mechanical bowel preparation arm with oral antibiotics Orally administered preparation of polyethylene glycol 2 days before surgery+ three doses of rifaximin 400mg at 7am, 3pm and 11pm the day before surgery and a single dose of metronidazole 500mg 11pm the day before surgery.
干预措施: Rifampicin (R) (Drug)
Mechanical bowel preparation without oral antibiotics
Mechanical bowel preparation alone Orally administered preparation of polyethylene glycol 2 days before surgery
结局指标
主要结局
Surgical Site Infection (SSI)
时间窗: 30 days
Any SSI and the type of SSI (superficial, deep incisional, and organ space) within 30 days of the index procedure based on the Centers for Disease Control and Prevention and National Nosocomial Infection Society criteria
次要结局
- anastomotic leak(30 days)
