Perioperative selective decontamination of the digestive tract (SDD) in elective colorectal cancer patients: a multicenter randomized clinical trial - SELECT trial

VU medical center0 个研究点目标入组 762 人开始时间: 2012年11月7日最近更新: 2020年11月16日

适应症

试验速览

暂无简介。

•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 762
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Previous colorectal surgery
•Inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
•Other malignancy
•Other malignancies in medical history
•Surgery for diverticular disease
•Performance status > ASA 3 (American Society for Anaesthesiologists)
•Expected adverse reactions/allergies for study medication
•Closure of temporary colostomy or ileostomy
•Immunocompromised patients (prednisone)
•Familial adenomatous polyposis coli (FAP; Lynch syndrome), Hereditary Non Polyposis Colorectal Cancer (HNPCC)
•Preoperative evidence of metastases
•Mental disorder/unable to give informed consent

发起方

VU medical center