Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (COLONPREP Study)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 193
- 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 colon cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.
Our Hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic colon cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.
详细描述
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 SSI. However, several randomized-controlled trials (RCT) and meta-analyses, have suggested the absence of benefit, in term of postoperative morbidity, of preoperative MBP before elective colon cancer surgery. A meta-analysis of RCT, comparing MBP to no-MBP before elective colon cancer surgery, even suggested that MBP could be associated with an increased SSI rate, as compared to no-MBP. These results led the latest French surgical guidelines of the Société Française de Chirurgie Digestive (SFCD) to recommend the absence of MBP before elective colon cancer surgery.
However, 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. This latter study reported a 50% reduction of SSI rate in the "MBP and oral antibiotics" group, as compared to the "MBP alone" group. Finally, three recent large retrospective registry studies compared the outcomes of four different strategies of preoperative colonic preparation before colorectal surgery: 1) MBP and oral antibiotics, 2) MBP alone, 3) Oral antibiotics alone, and 4) No colonic preparation. However, to date, no RCT has compared the "No preparation" group, which is the gold standard according to the international and French guidelines, to the "MBP and oral antibiotics" group.
The present study is therefore the first double-blinded RCT to compare the SSI rate for 4 types of colonic preparation before elective laparoscopic colonic surgery: 1) MBP and oral antibiotics, 2) MBP alone, 3) Oral antibiotics alone, and 4) No preparation.
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
Double Blind : 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 segmental colectomy for colon cancer
- •With Signed consent
- •And affiliated to the French social security system
排除标准
- •Emergent surgery
- •Scheduled total or subtotal colectomy (defined as a colectomy extended from the right colon to a least the left colonic angle)
- •Scheduled transverse colectomy
- •Scheduled associated proctectomy
- •Scheduled associated concomitant resection of another organ (liver, etc.), except the abdominal wall
- •Previous segmental colectomy
- •Associated inflammatory bowel disease
- •Active bacterial infection at the time of surgery or recent antimicrobial therapy (up to 2 weeks before surgery)
- •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
- Sennosides colonic preparation (X-PREP) :
1 per day, on day -2 and day -1.
- Gentamycin :
80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials.
- Ornidazole :
- g per day (2 tablet per day), on day -2 and day -1; In tablets.
干预措施: Sennosides colonic preparation (Drug)
1) " MBP and oral antibiotics " group
Sennosides colonic preparation Oral Gentamycin Oral Ornidazole
- Sennosides colonic preparation (X-PREP) :
1 per day, on day -2 and day -1.
- Gentamycin :
80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials.
- Ornidazole :
- g per day (2 tablet per day), on day -2 and day -1; In tablets.
干预措施: Oral Gentamycin (Drug)
1) " MBP and oral antibiotics " group
Sennosides colonic preparation Oral Gentamycin Oral Ornidazole
- Sennosides colonic preparation (X-PREP) :
1 per day, on day -2 and day -1.
- Gentamycin :
80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials.
- Ornidazole :
- g per day (2 tablet per day), on day -2 and day -1; In tablets.
干预措施: Oral Ornidazole (Drug)
2) " MBP alone " group
Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole
- Sennosides colonic preparation (X-PREP) :
1 per day, on day -2 and day -1.
- Placebo for oral gentamycin:
Same presentation as oral gentamycin x4 per day on day -2 and day -1. - Placebo for oral ornidazole : Same presentation as oral ornidazole
1g per day (2 tablet per day) on day -2 and day -1.
干预措施: Sennosides colonic preparation (Drug)
2) " MBP alone " group
Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole
- Sennosides colonic preparation (X-PREP) :
1 per day, on day -2 and day -1.
- Placebo for oral gentamycin:
Same presentation as oral gentamycin x4 per day on day -2 and day -1. - Placebo for oral ornidazole : Same presentation as oral ornidazole
1g per day (2 tablet per day) on day -2 and day -1.
干预措施: Oral placebo Gentamycin (Drug)
2) " MBP alone " group
Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole
- Sennosides colonic preparation (X-PREP) :
1 per day, on day -2 and day -1.
- Placebo for oral gentamycin:
Same presentation as oral gentamycin x4 per day on day -2 and day -1. - Placebo for oral ornidazole : Same presentation as oral ornidazole
1g per day (2 tablet per day) on day -2 and day -1.
干预措施: Oral placebo Ornidazole (Drug)
3) " Oral antibiotics alone " group
Oral Gentamycin Oral Ornidazole
- Gentamycin :
80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials.
- Ornidazole :
- g per day (2 tablet per day), on day -2 and day -1; In tablets.
干预措施: Oral Gentamycin (Drug)
3) " Oral antibiotics alone " group
Oral Gentamycin Oral Ornidazole
- Gentamycin :
80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials.
- Ornidazole :
- g per day (2 tablet per day), on day -2 and day -1; In tablets.
干预措施: Oral Ornidazole (Drug)
4) " No preparation " group
Oral placebo Gentamycin Oral placebo Ornidazole
-
Placebo for oral gentamycin : Same presentation as oral gentamycin x4 per day on day -2 and day -1
-
Placebo for oral ornidazole : Same presentation as oral ornidazole
1g per day (2 tablet per day) on day -2 and day -1
干预措施: Oral placebo Gentamycin (Drug)
4) " No preparation " group
Oral placebo Gentamycin Oral placebo Ornidazole
-
Placebo for oral gentamycin : Same presentation as oral gentamycin x4 per day on day -2 and day -1
-
Placebo for oral ornidazole : Same presentation as oral ornidazole
1g per day (2 tablet per day) on day -2 and day -1
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
- Tolerance of the colonic preparation(The day before surgery)
- Rate of multi-resistant bacteria carriage(The day before or the day of surgery)
- Postoperative length of hospital stay(Day of hospital discharge)
- Clostridium difficile colitis occurrence(30 days)
- Unplanned hospitalization(90 days)
- Date of adjuvant chemotherapy beginning(During 90 days)
- Overall postoperative morbidity(30 days)
- Postoperative mortality(30 days)
- Postoperative anastomotic leakage(90 days)
- Severe postoperative morbidity(30 days)