Oral Antibiotic Prophylaxis in Colorectal Surgery

Surgical Site Infection Clinical Trial

— ABCR  

Official title:

Mechanical Bowel Preparation and Oral Antibiotic Prophylaxis vs. Mechanical Bowel Preparation in Colorectal Surgery With i.v. Antibiotic Prophylaxis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03759886
• Other study ID #: ABCR
• Status: Recruiting
• Start date: December 17, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2020
• Source: University of Leipzig
• Contact: Boris Jansen-Winkeln, PD Dr.
• Phone: +49-314-97
• Email: boris.jansen-winkeln[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all colorectal resections

Exclusion Criteria:

• allergy

Related Conditions & MeSH terms

• Anastomotic Leak
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Paromomycin Sulfate Powder
The patients receive Paromomycin and Metronidazole the day prior to colorectal surgery after mechanical bowel preparation

Locations

Country	Name	City	State
Germany	Universitätsklinikum Leipzig - AöR	Leipzig	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infections	Any kind of surgical site infection in the postoperative course.	30 days (exact 30 days after the Operation date)
Secondary	Anastomotic Leak	All with objective methods proven anastomotic leakage (like contrast enema, re-operation or endoscopy)	30 days (exact 30 days after the Operation date)