Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Cancer Resections Versus no Bowel Preparation
NCT ID: NCT05546892
Last Updated: 2023-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
586 participants
INTERVENTIONAL
2023-02-10
2025-09-30
Brief Summary
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Detailed Description
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Short-term outcomes are assessed in 30 day period after surgery. This is a superiority trial evaluating statistical superiority. Rate of anastomotic leak is anticipated to decrease from 8% (data from local registry) to 3%. For power of 80% enrolment of 586 patients is required.
The intent-to-treat principle is used for the data analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Full bowel preparation (MBP+OA)
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
Full bowel preparation prior to colon resection for cancer
Mechanical bowel preparation and oral antibiotics
No bowel preparation
No bowel preparation (enema of not more then 500 ml is allowed prior or during surgery)
No bowel preparation
Omission of any bowel preparation
Interventions
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Full bowel preparation prior to colon resection for cancer
Mechanical bowel preparation and oral antibiotics
No bowel preparation
Omission of any bowel preparation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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N.N. Petrov National Medical Research Center of Oncology
OTHER
Responsible Party
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Principal Investigators
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Aleksei Karachun
Role: STUDY_CHAIR
N.N. Petrov National Medical Research Center of Oncology
Locations
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N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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COL-2
Identifier Type: -
Identifier Source: org_study_id
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