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

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

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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.