Perioperative Selective Decontamination of the Digestive Tract (SDD) in Elective Colorectal Cancer Patients: a Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 485
- 试验地点
- 5
- 主要终点
- anastomotic leakage and/or abscess
研究概览
简要总结
The primary objectives of this randomized clinical trial are to evaluate if perioperative SDD can reduce clinical anastomotic leakage rate and its septic consequences as well as other infectious complications. By reduction of septic complications long-term oncological outcome might simultaneously improve.
详细描述
Rationale:
Infectious complications and especially anastomotic leakage severely impede the recuperation of patients following colorectal cancer surgery. When the normal gut barrier fails such as in anastomotic leakage, pathogenic microorganisms like Gram-negative bacteria enter the circulation and may cause severe sepsis which is associated with considerable mortality. Moreover, anastomotic leakage has a negative impact on colorectal cancer prognosis. Selective decontamination of the digestive tract (SDD) is a prophylaxis regimen that employs oral nonabsorbable antibiotics to eradicate pathogenic micro-organisms like Gram-negative bacteria.
Objective:
The primary objectives of this randomized clinical trial are to evaluate if perioperative SDD can reduce clinical anastomotic leakage rate and its septic consequences as well as other infectious complications. By reduction of septic complications long-term oncological outcome might simultaneously improve. Secondary objectives are a decline in reoperation rate, in-hospital mortality, readmission rate, duration of hospital stay and ICU admission, non-infectious complications, improvement of quality of life and reduction of costs.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective colon and rectal cancer surgery with primary anastomosis
- •Or elective colorectal surgery for suspected carcinoma
- •No evidence of distant metastases (preoperative CT-abdomen and X-thorax or CTthorax)
- •Procedure either with or without diverting stoma
- •Both laparoscopic and open surgery
- •Informed consent
- •Aged 18 years or older
排除标准
- •Previous colorectal malignancy
- •Current malignancy which is now undergoing treatment
- •Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- •Previous surgery for diverticular disease
- •Performance status ASA 4 or higher (American Society for Anaesthesiologists)
- •Expected adverse reactions/allergies for study medication
- •Prednisone use > 5 mg per day
- •Familial adenomatous polyposis coli (FAP; Lynch syndrome), Hereditary Non Polyposis Colorectal Cancer (HNPCC)
- •Mental disorder/unable to give informed consent
- •Pregnancy
研究组 & 干预措施
Selective decontamination of the digestive tract (SDD)
Standard treatment + SDD perioperatively 4 times daily 10 ml of SDD suspension, consisting of 100mg colistin sulfate, 80mg tobramycin and 500mg of amphotericin B.
SDD treatment starts 3 days before surgery and is continued until at least 3 days postoperatively.
干预措施: Selective decontamination of the digestive tract (SDD) (colistin sulfate, tobramycin, amphotericin B) (Drug)
结局指标
主要结局
anastomotic leakage and/or abscess
时间窗: 30 days postoperatively
clinical and/or radiological evidence of anastomotic dehiscence requiring surgical or radiological (re)intervention.
次要结局
- Disease free survival(3 and 5 years after inclusion)
研究者
H. Jaap Bonjer, PhD
Professor of Surgery
Amsterdam UMC, location VUmc