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

H

Helsinki University Central Hospital (HUCH)

Status and phase

Unknown
Phase 4

Conditions

Colorectal Surgery

Treatments

Drug: neomycin, metronidazole, polyethylene glycol (PEG)

Study type

Interventional

Funder types

Other

Identifiers

NCT02652637
HYKS-MOBILE

Details and patient eligibility

About

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.

Enrollment

417 patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

417 participants in 2 patient groups

Mechanical and oral antibiotic bowel preparation
Experimental group
Description:
Mechanical bowel preparation using PEG, neomycin 2g p.o. (single-dose), and metronidazole 2g p.o. (single dose) are given the day before surgery.
Treatment:
Drug: neomycin, metronidazole, polyethylene glycol (PEG)
No bowel preparation
No Intervention group
Description:
No mechanical bowel preparation or oral antibiotics.

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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