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

August 21, 2020 updated by: Ville Sallinen, Helsinki University Central Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital
      • Jyvaskyla, Finland
        • Central Finland Central Hospital
      • Oulu, Finland
        • Oulu University Hospital
      • Seinäjoki, Finland
        • Seinäjoki Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: neomycin, metronidazole, polyethylene glycol (PEG)
No Intervention: No bowel preparation
No mechanical bowel preparation or oral antibiotics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Surgical site infection (CDC criteria)
Time Frame: 30 days from operation
30 days from operation

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
5-year overall survival
Time Frame: 5 years from operation
5 years from operation
5-year disease specific survival
Time Frame: 5 years from operation
5 years from operation
5-year recurrence free survival
Time Frame: 5 years from operation
5 years from operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 8, 2016

First Posted (Estimate)

January 12, 2016

Study Record Updates

Last Update Posted (Actual)

August 24, 2020

Last Update Submitted That Met QC Criteria

August 21, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYKS-MOBILE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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