NL-OMON44116CompletedPhase 3
Perioperative selective decontamination of the digestive tract (SDD) in elective colorectal cancer patients: a multicenter randomized clinical trial - SELECT trial
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 762
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •* 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
Exclusion Criteria
- •* 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
Investigators
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