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

Study Overview
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Brief Summary
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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.

Official Title
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Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery - a Prospective, Randomized Controlled Trial

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

Intervention / Treatment
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* Drug: Oral Antibiotics
* Drug: Placebo
* Drug: Mechanical Bowel Preparation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mechanical Bowel Preparation and Oral Antibiotics<br>Mechanical Bowel Preparation and Oral Antibiotics | Drug: Oral Antibiotics<br>* Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)<br>Drug: Mechanical Bowel Preparation<br>* Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)<br>|
| Active Comparator: Mechanical Bowel Preparation Only<br>Mechanical Bowel Preparation Only | Drug: Placebo<br>* Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)<br>Drug: Mechanical Bowel Preparation<br>* Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive Complication Index | Comprehensive Complication Index score | Within 30 days from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infection | Surgical site infection as defined by CDC | Within 30 days from surgery | 
| Anastomotic dehiscence | Anastomotic dehiscence | Within 30 days from surgery | 
| Lenght of hospital stay | Lenght of hospital stay | Within hospital stay, estimated on average 7 days | 
| Mortality | Mortality | Within 90 days from surgery | 
| Adjuvant therapy | Patients receiving adjuvant therapy divided by patients needing adjuvant therapy | Within 6 months from surgery |