MOBILE Trial. Mechanical and Oral Antibiotic Bowel Preparation Versus no Bowel preparatIon for eLEctive Colectomy - a Multicenter, Prospective, Randomized, Controlled Trial.

Study Overview
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Brief Summary
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Enchanced recovery after surgery (ERAS) protocols aim to provide safer and quicker recovery postoperatively. One of the elements in ERAS protocols is that bowel is not prepared before colorectal surgery. However, several recent retrospective register studies have suggested that mechanical bowel preparation combined to oral antibiotics before colectomy reduces complications compared to no preparation at all. This trial compares these two strategies to find out whether complications can indeed be reduced by mechanically preparing the bowel with oral antibiotics.

Official Title
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MOBILE Trial. Mechanical and Oral Antibiotic Bowel Preparation Versus no Bowel preparatIon for eLEctive Colectomy - a Multicenter, Prospective, Randomized, Controlled Trial.

Conditions
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Colorectal Surgery

Intervention / Treatment
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* Drug: neomycin, metronidazole, polyethylene glycol (PEG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing colon resection Exclusion Criteria: Emergency surgery needed Bowel obstruction Colonoscopy scheduled to be undertaken peroperatively Other reason indicating mechanical preparation or contradicting it Allergy to used drugs (PEG, neomycin, metronidazole)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mechanical and oral antibiotic bowel preparation<br>Mechanical bowel preparation using PEG, neomycin 2g p.o. (single-dose), and metronidazole 2g p.o. (single dose) are given the day before surgery. | Drug: neomycin, metronidazole, polyethylene glycol (PEG)<br> <br> |
| No Intervention: No bowel preparation<br>No mechanical bowel preparation or oral antibiotics. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection (CDC criteria) |  | 30 days from operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive Complication Index |  | 30 days from operation | 
| Anastomotic dehiscence |  | 30 days from operation | 
| Reoperations |  | 30 days from operation | 
| Readmissions |  | 30 days from operation | 
| Length of hospital stay |  | During hospital stay, anticipated 2-30 days | 
| Mortality |  | 30- and 90-days from operation | 
| Adverse effects of antibiotics (diarrhea, clostridium) |  | 30 days from operation | 
| Patients receiving adjuvant therapy divided by patients needing adjuvant therapy |  | 6 months from operation |