Oral Antibiotic Prophylaxis in Colorectal Surgery (ABCR)

January 6, 2020 updated by: Dr. Boris Jansen-Winkeln, University of Leipzig

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • Universitätsklinikum Leipzig - AöR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All Patients wich receive elective colorectal surgery.

Description

Inclusion Criteria:

  • all colorectal resections

Exclusion Criteria:

  • allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Paromomycin Sulfate Powder
The patients receive Paromomycin and Metronidazole the day prior to colorectal surgery after mechanical bowel preparation
Other Names:
  • Metronidazole
iv Antibiotics
The patients get mechanical bowel preparation and perioperative i.v. antibiotic prophylaxis with Ertepanem 1g i.v.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Infections
Time Frame: 30 days (exact 30 days after the Operation date)
Any kind of surgical site infection in the postoperative course.
30 days (exact 30 days after the Operation date)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Principal Investigator: Boris Jansen-Winkeln, PD Dr., University of Leipzig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2018

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 16, 2018

First Submitted That Met QC Criteria

November 29, 2018

First Posted (Actual)

November 30, 2018

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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