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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02652637

Enrollment

417

Registered

2016-01-12

Start date

2016-03-31

Completion date

2023-08-31

Last updated

2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Surgery

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.

Interventions

DRUGneomycin, metronidazole, polyethylene glycol (PEG)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

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)

Design outcomes

Primary

Measure	Time frame
Surgical site infection (CDC criteria)	30 days from operation

Secondary

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

Other

Measure	Time frame
5-year disease specific survival	5 years from operation
5-year recurrence free survival	5 years from operation
5-year overall survival	5 years from operation

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026