<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03759886</url>
  </required_header>
  <id_info>
    <org_study_id>ABCR</org_study_id>
    <nct_id>NCT03759886</nct_id>
  </id_info>
  <brief_title>Oral Antibiotic Prophylaxis in Colorectal Surgery</brief_title>
  <acronym>ABCR</acronym>
  <official_title>Mechanical Bowel Preparation and Oral Antibiotic Prophylaxis vs. Mechanical Bowel Preparation in Colorectal Surgery With i.v. Antibiotic Prophylaxis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leipzig</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Leipzig</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators perform a case-control study to compare preparation before elective&#xD;
      colorectal surgery. The first group is a prospective patient - registry in all patients with&#xD;
      mechanical bowel preparation (MBP) and oral antibiotic prophylaxis the day before colorectal&#xD;
      surgery. The second group is a historic collective of patients with MBP only and colorectal&#xD;
      surgery. The cases were matches in American Society of Anesthesiologists (ASA) physical&#xD;
      status classification system, BMI, operative procedure and risk factors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>30 Days</target_duration>
  <primary_outcome>
    <measure>Surgical Site Infections</measure>
    <time_frame>30 days (exact 30 days after the Operation date)</time_frame>
    <description>Any kind of surgical site infection in the postoperative course.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anastomotic Leak</measure>
    <time_frame>30 days (exact 30 days after the Operation date)</time_frame>
    <description>All with objective methods proven anastomotic leakage (like contrast enema, re-operation or endoscopy)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Surgical Site Infection</condition>
  <condition>Anastomotic Leak</condition>
  <arm_group>
    <arm_group_label>Oral Antibiotics</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>iv Antibiotics</arm_group_label>
    <description>The patients get mechanical bowel preparation and perioperative i.v. antibiotic prophylaxis with Ertepanem 1g i.v.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paromomycin Sulfate Powder</intervention_name>
    <description>The patients receive Paromomycin and Metronidazole the day prior to colorectal surgery after mechanical bowel preparation</description>
    <arm_group_label>Oral Antibiotics</arm_group_label>
    <other_name>Metronidazole</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All Patients wich receive elective colorectal surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all colorectal resections&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boris Jansen-Winkeln, PD Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leipzig</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Boris Jansen-Winkeln, PD Dr.</last_name>
    <phone>+49-314-97</phone>
    <phone_ext>17200</phone_ext>
    <email>boris.jansen-winkeln@medizin.uni-leipzig.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ines Gockel, Prof. Dr.</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universitätsklinikum Leipzig - AöR</name>
      <address>
        <city>Leipzig</city>
        <state>Sachsen</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>January 6, 2020</last_update_submitted>
  <last_update_submitted_qc>January 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Leipzig</investigator_affiliation>
    <investigator_full_name>Dr. Boris Jansen-Winkeln</investigator_full_name>
    <investigator_title>Consultant Colorectal Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Anastomotic Leak</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
    <mesh_term>Paromomycin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03759886
org study id: ABCR
nct id: NCT03759886
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Control
time perspective: Prospective
measure: Surgical Site Infections
time frame: 30 days (exact 30 days after the Operation date)
description: Any kind of surgical site infection in the postoperative course.
measure: Anastomotic Leak
time frame: 30 days (exact 30 days after the Operation date)
description: All with objective methods proven anastomotic leakage (like contrast enema, re-operation or endoscopy)
arm group label: Oral Antibiotics
description: 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.
arm group label: iv Antibiotics
description: The patients get mechanical bowel preparation and perioperative i.v. antibiotic prophylaxis with Ertepanem 1g i.v.
intervention type: Drug
intervention name: Paromomycin Sulfate Powder
description: The patients receive Paromomycin and Metronidazole the day prior to colorectal surgery after mechanical bowel preparation
arm group label: Oral Antibiotics
other name: Metronidazole
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Boris Jansen-Winkeln, PD Dr.
role: Principal Investigator
affiliation: University of Leipzig
last name: Boris Jansen-Winkeln, PD Dr.
phone: +49-314-97
phone ext: 17200
email: boris.jansen-winkeln@medizin.uni-leipzig.de
last name: Ines Gockel, Prof. Dr.
facility: 
status: Recruiting
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Leipzig
investigator full name: Dr. Boris Jansen-Winkeln
investigator title: Consultant Colorectal Surgery
mesh term: Surgical Wound Infection
mesh term: Anastomotic Leak
mesh term: Metronidazole
mesh term: Paromomycin
sharing ipd: Undecided