NCT02652637

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
417

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

August 24, 2020

Status Verified

August 1, 2020

Enrollment Period

2.5 years

First QC Date

January 8, 2016

Last Update Submit

August 21, 2020

Conditions

Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

  • Surgical site infection (CDC criteria)

    30 days from operation

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Other Outcomes (3)

  • 5-year overall survival

    5 years from operation

  • 5-year disease specific survival

    5 years from operation

  • 5-year recurrence free survival

    5 years from operation

Study Arms (2)

Mechanical and oral antibiotic bowel preparation

EXPERIMENTAL

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 bowel preparation

NO INTERVENTION

No mechanical bowel preparation or oral antibiotics.

Interventions

neomycin, metronidazole, polyethylene glycol (PEG)DRUG
Mechanical and oral antibiotic bowel preparation

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing colon resection

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Central Finland Central Hospital

Jyväskylä, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Seinäjoki Central Hospital

Seinäjoki, Finland

Location

Related Publications (1)

  • Koskenvuo L, Lehtonen T, Koskensalo S, Rasilainen S, Klintrup K, Ehrlich A, Pinta T, Scheinin T, Sallinen V. Mechanical and oral antibiotic bowel preparation versus no bowel preparation for elective colectomy (MOBILE): a multicentre, randomised, parallel, single-blinded trial. Lancet. 2019 Sep 7;394(10201):840-848. doi: 10.1016/S0140-6736(19)31269-3. Epub 2019 Aug 8.

    PMID: 31402112DERIVED

MeSH Terms

Interventions

NeomycinMetronidazolePolyethylene Glycols

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydratesNitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEthylene GlycolsGlycolsAlcoholsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 12, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2018

Study Completion

August 1, 2023

Last Updated

August 24, 2020

Record last verified: 2020-08

Locations

FI(4)