NL-OMON44116已完成3 期
Perioperative selective decontamination of the digestive tract (SDD) in elective colorectal cancer patients: a multicenter randomized clinical trial - SELECT trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 762
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Elective colon and rectal cancer surgery with primary anastomosis
- •* No evidence of distant metastases (preoperative CT-abdomen and X-thorax or CT-thorax)
- •* Procedure either with or without diverting stoma
- •* Both laparoscopic and open surgery
- •* Informed consent
排除标准
- •* Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- •* A history of colorectal malignancy
- •* Current malignancy now undergoing treatment
- •* Previous surgery for diverticulitis / diverticulosis
- •* Performance status ASA 4 or higher (American Society of Anaesthesiologists)
- •* Expected reactions / allergies to the study medication
- •* Reversal of a temporary colostomy or ileostomy
- •* Prednisone use of more than 5 mg per day
- •* Familial adenomatous polyposis coli (FAP, Lynch syndrome), Hereditary Non Polyposis Colorectal Cancer (HNPCC)
- •* Inability to give informed consent
- •* Pregnancy
研究者
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