Clinical trial NCT02652637: MOBILE Trial. Mechanical and Oral Antibiotic Bowel Preparation Versus no Bowel preparatIon for eLEctive Colectomy - a Multicenter, Prospective, Randomized, Controlled Trial.
Official title: MOBILE Trial. Mechanical and Oral Antibiotic Bowel Preparation Versus no Bowel preparatIon for eLEctive Colectomy - a Multicenter, Prospective, Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colorectal Surgery
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Surgical site infection (CDC criteria)
timeFrame: 30 days from operation
Secondary outcomes:
measure: Comprehensive Complication Index
timeFrame: 30 days from operation
measure: Anastomotic dehiscence
timeFrame: 30 days from operation
measure: Reoperations
timeFrame: 30 days from operation
measure: Readmissions
timeFrame: 30 days from operation
measure: Length of hospital stay
timeFrame: During hospital stay, anticipated 2-30 days
measure: Mortality
timeFrame: 30- and 90-days from operation
measure: Adverse effects of antibiotics (diarrhea, clostridium)
timeFrame: 30 days from operation
measure: Patients receiving adjuvant therapy divided by patients needing adjuvant therapy
timeFrame: 6 months from operation
Other outcomes:
measure: 5-year overall survival
timeFrame: 5 years from operation
measure: 5-year disease specific survival
timeFrame: 5 years from operation
measure: 5-year recurrence free survival
timeFrame: 5 years from operation
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Jyvaskyla
country: Finland
facility: Central Finland Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Seinäjoki
country: Finland
facility: Seinäjoki Central Hospital
Study officials:
References:
citation: Koskenvuo L, Lehtonen T, Koskensalo S, Rasilainen S, Klintrup K, Ehrlich A, Pinta T, Scheinin T, Sallinen V. Mechanical and oral antibiotic bowel preparation versus no bowel preparation for elective colectomy (MOBILE): a multicentre, randomised, parallel, single-blinded trial. Lancet. 2019 Sep 7;394(10201):840-848. doi: 10.1016/S0140-6736(19)31269-3. Epub 2019 Aug 8.