Study name |
Mechanical Bowel Preparation With or Without Oral Antibiotics for Colorectal Cancer Surgery (MECCA) |
Methods |
Study type: interventional (Clinical Trial) Study design
Allocation: randomised
Interventional model: Sequential Assignment
Masking: triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: prevention
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Participants |
Condition or disease: Antibiotic, Bowel Cancer, Colorectal Cancer, Surgical Site Infection Inclusion criteria
Exclusion criteria
Emergency surgery
Obstructive and perforated cancer
Intolerance to bowel preparation regimen
Allergies to orally administered antibiotics
Target sample size: 105 |
Interventions |
Treatment arms
Bowel Preparation plus antibiotics: preoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500 mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with mechanical bowel preparation (2 vials sodium phospate 45 mL at 1:00 and 7:00 pm)
Bowel preparation: preoperative mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)
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Outcomes |
Primary outcome
Secondary outcomes
Anastomotic leaks [Time Frame: 30 days]
Other surgical and non‐surgical complications [Time Frame: 30 days]
Hospital length of stay [Time Frame: 30 days]
Readmission rate [Time Frame: 30 days]
Patients' preparation tolerance [Time Frame: 30 days]
Preparation regimens side effects [Time Frame: 30 days]
Time to beginning of adjuvant treatment for colorectal cancer [Time Frame: 60 days]
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Starting date |
Date of registration: June 9, 2018 Study Start Date: April 1, 2018 Estimated Primary Completion Date: April 1, 2021 Recruitment Status: Recruiting (Last Update Posted: September 11, 2020) |
Contact information |
Contact person: George Theodoropoulos Affiliation: National and Kapodistrian University of Athens Country of origin: Greece |
Notes |
Ethics approval: ‐ Source of funding: National and Kapodistrian University of Athens |