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

Colorectal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02652637
• Other study ID #: HYKS-MOBILE
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: August 2023

Study information

• Verified date: August 2020
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 417
• Est. completion date: August 2023
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

Drug:
• neomycin, metronidazole, polyethylene glycol (PEG)

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
Finland	Central Finland Central Hospital	Jyvaskyla
Finland	Oulu University Hospital	Oulu
Finland	Seinäjoki Central Hospital	Seinäjoki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	5-year overall survival		5 years from operation
Other	5-year disease specific survival		5 years from operation
Other	5-year recurrence free survival		5 years from operation
Primary	Surgical site infection (CDC criteria)		30 days from operation
Secondary	Comprehensive Complication Index		30 days from operation
Secondary	Anastomotic dehiscence		30 days from operation
Secondary	Reoperations		30 days from operation
Secondary	Readmissions		30 days from operation
Secondary	Length of hospital stay		During hospital stay, anticipated 2-30 days
Secondary	Mortality		30- and 90-days from operation
Secondary	Adverse effects of antibiotics (diarrhea, clostridium)		30 days from operation
Secondary	Patients receiving adjuvant therapy divided by patients needing adjuvant therapy		6 months from operation