Clinical trial · Interventional
Does Administration of Antibiotics in Patients Undergoing Surgery for Colorectal Cancer Result in Less Complications and Better Prognosis?
Perioperative Selective Decontamination of the Digestive Tract (SDD) in Elective Colorectal Cancer Patients: a Multicenter Randomized Clinical Trial
NCT01740947CI-TRIAL-00035723SELECTterminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Superiority was no longer attainable
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Selective decontamination of the digestive tract (SDD) (colistin sulfate, tobramycin, amphotericin B) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard treatment
- description
- Standard treatment for colorectal cancer
- type
- EXPERIMENTAL
- label
- Selective decontamination of the digestive tract (SDD)
- description
- 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.
- interventionNames
- Drug: Selective decontamination of the digestive tract (SDD) (colistin sulfate, tobramycin, amphotericin B)
Primary outcomes (1)
- measure
- anastomotic leakage and/or abscess
- timeFrame
- 30 days postoperatively
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (2)
- DERIVEDAbis GSA, Stockmann HBAC, Bonjer HJ, van Veenendaal N, van Doorn-Schepens MLM, Budding AE, Wilschut JA, van Egmond M, Oosterling SJ; SELECT trial study group. Randomized clinical trial of selective decontamination of the digestive tract in elective colorectal cancer surgery (SELECT trial). Br J Surg. 2019 Mar;106(4):355-363. doi: 10.1002/bjs.11117. Epub 2019 Feb 25. PMID 30802304
- DERIVEDAbis GS, Oosterling SJ, Stockmann HB, van der Bij GJ, van Egmond M, Vandenbroucke-Grauls CM, Bonjer HJ. Perioperative selective decontamination of the digestive tract and standard antibiotic prophylaxis versus standard antibiotic prophylaxis alone in elective colorectal cancer patients. Dan Med J. 2014 Apr;61(4):A4695. PMID 24814583