Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (PREPACOL2 Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- Postoperative 30-day surgical site infection (SSI).
研究概览
简要总结
This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone Our hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic rectal cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone
详细描述
This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone.
This study's hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic rectal cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone Preoperative mechanical bowel preparation (MBP) has been proposed in an attempt to reduce the colonic fecal load and to limit the risk of surgical site contamination, thus theoretically limiting the risk of postoperative surgical site infection (SSI). However, the benefit of such MBP before colorectal surgery is related to type of procedure performed. Indeed, several randomized controlled trials (RCT) and meta-analyses have demonstrated the absence of benefit of MBP before colon cancer surgery, whereas a recent RCT suggested that MBP before rectal cancer surgery was associated to a significant reduction of postoperative SSI, as compare to the absence of preoperative MBP.
Recent studies suggested that the adjunction of oral antibiotics during MBP could help efficiently reduce the risk of postoperative SSI. Indeed, a recent meta-analysis of RCT have suggested that patients preoperatively receiving both MBP and oral antibiotics were exposed to a significantly reduced risk of postoperative SSI, as compared to patients receiving only preoperative MBP. This result was confirmed in a recent RCT which compared preoperative MBP and oral antibiotics versus MBP alone in a heterogeneous population of patients who underwent laparoscopic colonic or rectal surgery. However, to date, no RCT compared the outcomes of an MBP with oral antibiotics to MBP without oral antibiotics in a homogeneous cohort of patients undergoing rectal cancer surgery.
This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone.
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
- Double (Participant, Investigator)
盲法说明
Both participants and investigators are unaware of the intervention assignment
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
- •Patients aged 18 or more
- •Scheduled to undergo elective restorative laparoscopic cancer of the rectal (<15 cm from the anal margin) with sphincter preservation
- •With Signed consent
- •And affiliated to the French social security system
排除标准
- •Emergent surgery
- •Scheduled total colo-proctectomy
- •Scheduled abdominoperineal restion with definitive colostomy
- •Scheduled associated concomitant resection of another organ (liver, etc.)
- •Active bacterial infection at the time of surgery or recent antibiotic therapy (up to 15 days before surgery)
- •Associated inflammatory bowel disease
- •Patients with known colonization with multidrug-resistant enterobacteriacea
- •History of allergy or contraindication to the Ornidazole, Gentamycin, X-PREP or to any of the excipients of the drugs used.
- •Cirrhosis of grade B and C (Child-Pugh classification)
- •Myasthenia
- •Allergy to one of the other treatments administered for the purpose of the trial (including betadine)
- •Patient suffering from severe central neurologic diseases, fixed or progressive.
- •Pregnant patients
- •Refusal to participate or inability to provide informed consent
研究组 & 干预措施
1) " MBP and oral antibiotics " group
Sennosides colonic preparation Oral Gentamycin Oral Ornidazole
干预措施: Sennosides colonic preparation (Drug)
1) " MBP and oral antibiotics " group
Sennosides colonic preparation Oral Gentamycin Oral Ornidazole
干预措施: Oral Gentamycin (Drug)
1) " MBP and oral antibiotics " group
Sennosides colonic preparation Oral Gentamycin Oral Ornidazole
干预措施: Oral Ornidazole (Drug)
2) " MBP alone " group
Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole
干预措施: Sennosides colonic preparation (Drug)
2) " MBP alone " group
Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole
干预措施: Oral Placebo Gentamycin (Drug)
2) " MBP alone " group
Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole
干预措施: Oral Placebo Ornidazole (Drug)
结局指标
主要结局
Postoperative 30-day surgical site infection (SSI).
时间窗: 30 days
SSI will be defined and classified as superficial, deep and/or organ-space infection on the basis of validated and well-defined criteria developed by the Centers for Disease Control and Prevention (CDC), validated in French by the Comité technique des infections nosocomiales et des infections liées aux soins.
次要结局
- Date of adjuvant chemotherapy beginning(90 days)
- Postoperative mortality(30 days)
- Postoperative length of hospital stay(Up to 90 days)
- Tolerance of the colonic preparation(The day before surgery)
- Temporary stoma closure rate(90 days)
- Rate of multi-resistant bacteria carriage(The day before or the day of surgery)
- Overall postoperative morbidity(30 days)
- Unplanned hospitalization(90 days)
- Severe postoperative morbidity(30 days)
- Postoperative anastomotic leakage(90 days)
- Clostridium difficile colitis occurrence(30 days)