Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Cancer Resections Versus no Bowel Preparation (COLRABI)
Colon Cancer
About this trial
This is an interventional treatment trial for Colon Cancer focused on measuring colon cancer, MBP, bowel preparation, oral antibiotics
Eligibility Criteria
Inclusion Criteria:
- histologically confirmed adenocarcinoma of the colon (caecum, ascending, transverse, descending, sigmoid)
- clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
- indications for surgical colonic resection
- ECOG status 0-2
- At least 18 years of age
- Written informed consent
Exclusion Criteria:
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
- Pregnancy or breast feeding
- Medical contraindications for surgical treatment
- Any use of antibiotics 30 days prior to inclusion
- Functioning stoma
- Contraindications for use of MBP or OA drugs or their components
- Indications for mandatory MBP (planned intraoperative colonoscopy etc)
- Indications for obstructive resection
- Acute bowel obstruction, bleeding or perforation
- Other malignancies not in remission
Sites / Locations
- N.N. Petrov National Medical Research Center of OncologyRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Full bowel preparation (MBP+OA)
No bowel preparation
Rifaximin 400 mg twice daily for three days prior to surgery Day prior to surgery: 17.00 - 18.00 Macrogol-3350 - 100 g Natrium sulfate - 7,5 g Natrium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Natrii ascorbate - 5,9 g Clear fluids - 1000 ml 18.00 - 19.00 Clear fluids 500 ml 19.00 - 20.00 Macrogol-3350 - 100 g Natrium sulfate - 7,5 g Natrium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Natrii ascorbate - 5,9 g Clear fluids - 1000 ml 20.00 - 21.00 Clear fluids 500 ml
No bowel preparation (enema of not more then 500 ml is allowed prior or during surgery)