Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery (MOBILE2)

Helsinki University Central Hospital (HUCH)

Status and phase: Active, not recruiting; Phase 4

Conditions: Colorectal Carcinoma; Rectal Adenocarcinoma; Surgical Site Infection; Surgery--Complications; Colorectal Neoplasms; Rectum Carcinoma; Rectum Neoplasm; Colorectal Cancer

Treatments: Drug: Oral Antibiotics; Drug: Mechanical Bowel Preparation; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04281667

14112018

Details and patient eligibility

About

MOBILE2 is a randomized controlled trial comparing mechanical and oral antibiotic bowel preparation to mechanical bowel preparation only in patients undergoing anterior rectal resection with primary anastomosis. Primary endpoint is Comprehensive Complication Index within 30 days from surgery.

Enrollment: 604 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for anterior rectal resection with primary anastomosis

Exclusion criteria

• Emergency operation
• Bowel obstruction
• Existing stoma
• Other reason preventing mechanical bowel preparation
• Allergy to neomycin or metronidazole
• Age < 18 years
• Lack of co-operation

Exclusion criteria after randomization:

• Patient did not undergo surgery
• Anterior resection was not performed
• Colonic anastomosis was not performed

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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604 participants in 2 patient groups

Mechanical Bowel Preparation and Oral Antibiotics

Experimental group

Description:

Mechanical Bowel Preparation and Oral Antibiotics

Treatment:

Drug: Mechanical Bowel Preparation

Drug: Oral Antibiotics

Mechanical Bowel Preparation Only

Active Comparator group

Description:

Mechanical Bowel Preparation Only

Treatment:

Drug: Mechanical Bowel Preparation

Drug: Placebo