Mechanical Bowel Preparation With or Without Oral Antibiotics for Colorectal Cancer Surgery
- Conditions
- Bowel CancerColorectal CancerSurgical Site InfectionAntibiotic
- Interventions
- Other: Bowel PreparationOther: Bowel Preparation plus antibiotics
- Registration Number
- NCT03563586
- Lead Sponsor
- National and Kapodistrian University of Athens
- Brief Summary
Investigation of the role of adding oral antibiotics to preoperative mechanical bowel preparation before colorectal surgery for cancer.
- Detailed Description
The aim of the study is to investigate whether the addition of oral antibiotics to Mechanical Bowel Preparation (MBP) prior to colorectal cancer surgical procedures reduce the superfical and deep surgical site (SSI) infectious complications. The study is prospective and is designed in a randomized single-blinded controlled fashion. It is taking place at one academic surgical unit of Athens Medical School, located at a tertiary referal institution. Patients scheduled to undergo an elective surgical resection for colon or rectal cancer will be allocated to either formal MBP the day before surgery or a combined MBP with administration of oral antibiotics. Exclusion criteria are the following: emergency surgery, obstructive or perforated cancer, patients intolerance to bowel preparation regimen and allergies to orally administered antibiotics.
Intervention arms: Patients will be randomised into two groups, concealed from the treating surgeon.
Group A:
Preoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with MBP (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)
Group B:
MBP (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) alone Both groups will receive iv antibiotics (cefoxitin 2 gr plus metronidazole 500gr) perioperatively and discontinuation within 24 hours.
Outcome measures: The primary end point is surgical site infection (SSI), including (i) superficial wound infection, (ii) deep wound infection, and (iii) intrabdominal infection (contaminated fluid or pus collection) within 30 days of the procedure (decrease 3% in the rate) Secondary measures: Anastomotic leaks, other surgical and non-surgical compliactions, hospital length of stay, readmission rate, patients' preparation tolerance, preparation regimens side-effects, time to beginning of adjuvant treatment for colorectal cancer.
Sample Size: It is estimated that 105 patients per treatment arm are needed.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 210
- Scheduled colorectal cancer surgery
- Emergency surgery
- Obstructive and perforated cancer
- Intolerance to bowel preparation regimen
- Allergies to orally administered antibiotics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Bowel Preparation Bowel Preparation Preoperative mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) Bowel Preparation plus antibiotics Bowel Preparation plus antibiotics Preoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)
- Primary Outcome Measures
Name Time Method Surgical Site Infections 30 days Surgical Site Infections
- Secondary Outcome Measures
Name Time Method Readmission rate 30 days Readmission rate
Anastomotic leaks 30 days Anastomotic leaks
Preparation regimens side-effects 30 days Preparation regimens side-effects
Other surgical and non-surgical compliactions 30 days Other surgical and non-surgical compliactions
Patients' preparation tolerance 30 days Patients' preparation tolerance
Hospital length of stay 30 days Hospital length of stay
Time to beginning of adjuvant treatment for colorectal cancer 60 days Time to beginning of adjuvant treatment for colorectal cancer
Trial Locations
- Locations (1)
NKUAthens
🇬🇷Athens, Greece