Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery

Phase 4Active Not RecruitingNCT04281667

Helsinki University Central Hospital604 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

604

Conditions

Rectal Adenocarcinoma Rectum Neoplasm Rectum Carcinoma Colorectal Cancer Colorectal Neoplasms Colorectal Carcinoma

Interventions

Oral AntibioticsDRUG

Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)

PlaceboDRUG

Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)

Mechanical Bowel PreparationDRUG

Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Helsinki University Hospital

Helsinki, Finland

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland

Outcomes

Primary Outcomes

Comprehensive Complication Index

Comprehensive Complication Index score

Time frame: Within 30 days from surgery

Secondary Outcomes

Surgical Site Infection

Surgical site infection as defined by CDC

Time frame: Within 30 days from surgery

Anastomotic dehiscence

Time frame: Within 30 days from surgery

Lenght of hospital stay

Time frame: Within hospital stay, estimated on average 7 days

Mortality

Time frame: Within 90 days from surgery

Adjuvant therapy

Patients receiving adjuvant therapy divided by patients needing adjuvant therapy

Time frame: Within 6 months from surgery