Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone (REPCA)

N.N. Petrov National Medical Research Center of Oncology

Status: Enrolling

Conditions: Rectal Cancer

Treatments: Procedure: Full bowel preparation; Procedure: Mechanical bowel preparation only

Study type: Interventional

Funder types: Other

Identifiers

NCT04592289

COL-3

Details and patient eligibility

About

The purpose of the study is to determine if short-term outcomes of rectal resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to rectal resections with only mechanical bowel preparation.

Full description

The design involves random allocation of eligible patients to full bowel preparation or only mechanical bowel preparation in 1:1 ratio. After that rectal 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 surgical site infection is anticipated to decrease from 12% (data from local registry) to 6%. For power of 80% enrolment of 622 patients is required.

The intent-to-treat principle is used for the data analysis.

Enrollment: 622 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed adenocarcinoma of the rectum or rectosigmoid junction
• clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
• indications for surgical rectal 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 obstructive resection or abdominoperineal excision
• 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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622 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 Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 18.00 - 19.00 Clear fluids 500 ml 19.00 - 20.00 17.00 - 18.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 20.00 - 21.00 Clear fluids 500 ml

Treatment:

Procedure: Full bowel preparation

Mechanical bowel preparation only

Active Comparator group

Description:

Day prior to surgery: 17.00 - 18.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 18.00 - 19.00 Clear fluids 500 ml 19.00 - 20.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 20.00 - 21.00 Clear fluids 500 ml

Treatment:

Procedure: Mechanical bowel preparation only