Oral Antibiotic Prophylaxis in Colorectal Surgery

• Conditions: Surgical Site Infection; Anastomotic Leak
• Interventions: Drug: Paromomycin Sulfate Powder

• Registration Number: NCT03759886
• Lead Sponsor: University of Leipzig

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-11-30
• Study Start: 2018-12-17
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07
• Primary Completion: 2020-05-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• all colorectal resections

Exclusion Criteria

• allergy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral Antibiotics	Paromomycin Sulfate Powder	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.

Primary Outcome Measures

Name	Time	Method
Surgical Site Infections	30 days (exact 30 days after the Operation date)	Any kind of surgical site infection in the postoperative course.

Secondary Outcome Measures

Name	Time	Method
Anastomotic Leak	30 days (exact 30 days after the Operation date)	All with objective methods proven anastomotic leakage (like contrast enema, re-operation or endoscopy)

Trial Locations

Locations (1)

Universitätsklinikum Leipzig - AöR; 🇩🇪 Leipzig, Sachsen, Germany