NCT04281667

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 604 (estimated)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Adenocarcinoma
• Rectum Neoplasm
• Rectum Carcinoma
• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Carcinoma
• Surgical Site Infection
• Surgery--Complications

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-03-18
• Primary completion: 2022-11-09
• Completion: 2027-10-10
• First posted: 2020-02-24
• Last updated: 2022-11-17

Locations

3 sites across 1 country: Finland