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

Phase 4

• Conditions: Colorectal Surgery
• Interventions: Drug: neomycin, metronidazole, polyethylene glycol (PEG)

• Registration Number: NCT02652637
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-08
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-12
• Study Start: 2016-03
• Primary Completion: 2018-09
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-21
• Last Update Posted: 2020-08-24
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 417

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mechanical and oral antibiotic bowel preparation	neomycin, metronidazole, polyethylene glycol (PEG)	Mechanical bowel preparation using PEG, neomycin 2g p.o. (single-dose), and metronidazole 2g p.o. (single dose) are given the day before surgery.

Primary Outcome Measures

Name	Time	Method
Surgical site infection (CDC criteria)	30 days from operation

Secondary Outcome Measures

Name	Time	Method
Comprehensive Complication Index	30 days from operation
Reoperations	30 days from operation
Patients receiving adjuvant therapy divided by patients needing adjuvant therapy	6 months from operation
Readmissions	30 days from operation
Anastomotic dehiscence	30 days from operation
Length of hospital stay	During hospital stay, anticipated 2-30 days
Mortality	30- and 90-days from operation
Adverse effects of antibiotics (diarrhea, clostridium)	30 days from operation

Trial Locations

Locations (4)

Seinäjoki Central Hospital; 🇫🇮 Seinäjoki, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Central Finland Central Hospital; 🇫🇮 Jyvaskyla, Finland

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland