Mechanical Bowel Preparation and Oral Antibiotic Prophylaxis vs. Mechanical Bowel Preparation in Colorectal Surgery With i.v. Antibiotic Prophylaxis
Overview
- Phase
- Not Applicable
- Intervention
- Paromomycin Sulfate Powder
- Conditions
- Surgical Site Infection
- Sponsor
- University of Leipzig
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Surgical Site Infections
- Last Updated
- 6 years ago
Overview
Brief Summary
The investigators perform a case-control study to compare preparation before elective colorectal surgery. The first group is a prospective patient - registry in all patients with mechanical bowel preparation (MBP) and oral antibiotic prophylaxis the day before colorectal surgery. The second group is a historic collective of patients with MBP only and colorectal surgery. The cases were matches in American Society of Anesthesiologists (ASA) physical status classification system, BMI, operative procedure and risk factors.
Investigators
Dr. Boris Jansen-Winkeln
Consultant Colorectal Surgery
University of Leipzig
Eligibility Criteria
Inclusion Criteria
- •all colorectal resections
Exclusion Criteria
- Not provided
Arms & Interventions
Oral Antibiotics
The patients get mechanical bowel preparation and oral antibiotic prophylaxis with 4g Paromomycin (Paromomycin Sulfate Powder) and 1 g Metronidazole p.o. and perioperative i.v. antibiotic prophylaxis with Ertepanem 1g i.v.
Intervention: Paromomycin Sulfate Powder
Outcomes
Primary Outcomes
Surgical Site Infections
Time Frame: 30 days (exact 30 days after the Operation date)
Any kind of surgical site infection in the postoperative course.
Secondary Outcomes
- Anastomotic Leak(30 days (exact 30 days after the Operation date))