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ACTIVE NOT RECRUITING
NCT04281667
PHASE4

Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery

Sponsor: Helsinki University Central Hospital

View on ClinicalTrials.gov

Summary

MOBILE2 is a randomized controlled trial comparing mechanical and oral antibiotic bowel preparation to mechanical bowel preparation only in patients undergoing anterior rectal resection with primary anastomosis. Primary endpoint is Comprehensive Complication Index within 30 days from surgery.

Official title: Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery - a Prospective, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

604

Start Date

2020-03-18

Completion Date

2027-10-10

Last Updated

2022-11-17

Healthy Volunteers

No

Interventions

DRUG

Oral Antibiotics

Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)

DRUG

Placebo

Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)

DRUG

Mechanical Bowel Preparation

Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)

Locations (3)

Helsinki University Hospital

Helsinki, Finland

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland