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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

417 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2023-08-31

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.

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Detailed Description

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Conditions

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Colorectal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Mechanical and oral antibiotic bowel preparation

Mechanical bowel preparation using PEG, neomycin 2g p.o. (single-dose), and metronidazole 2g p.o. (single dose) are given the day before surgery.

Group Type EXPERIMENTAL

neomycin, metronidazole, polyethylene glycol (PEG)

Intervention Type DRUG

No bowel preparation

No mechanical bowel preparation or oral antibiotics.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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neomycin, metronidazole, polyethylene glycol (PEG)

Intervention Type DRUG

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No