Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Cancer Resections Versus no Bowel Preparation (COLRABI)

N.N. Petrov National Medical Research Center of Oncology

Status: Enrolling

Conditions: Colon Cancer

Treatments: Procedure: No bowel preparation; Procedure: Full bowel preparation prior to colon resection for cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT05546892

COL-2

Details and patient eligibility

About

The purpose of the study is to determine if short-term outcomes of colon resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to colon resections with no bowel preparation.

Full description

The design involves random allocation of eligible patients to full bowel preparation or no bowel preparation in 1:1 ratio. After that colon resection is performed in both groups.

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.

Enrollment: 586 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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586 participants in 2 patient groups

Full bowel preparation (MBP+OA)

Experimental group

Description:

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

Treatment:

Procedure: Full bowel preparation prior to colon resection for cancer

No bowel preparation

Active Comparator group

Description:

No bowel preparation (enema of not more then 500 ml is allowed prior or during surgery)

Treatment:

Procedure: No bowel preparation