<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/NCT04438655</url>
  </required_header>
  <id_info>
    <org_study_id>Università di TORINO</org_study_id>
    <nct_id>NCT04438655</nct_id>
  </id_info>
  <brief_title>Prospective Randomized Clinical Trial on Oral and Intravenous Antibiotic Prophylaxis in Colorectal Surgery.</brief_title>
  <acronym>COLORAL1</acronym>
  <official_title>Prospective Randomized Clinical Trial on Oral and Intravenous Antibiotic Prophylaxis in Colorectal Surgery (COLORAL1).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turin, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Turin, Italy</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Elective colon surgery is considered a clean-contaminated procedure, with a Surgical Site&#xD;
      Infection (SSI) rate not inferior to 10%. For many years the role of Mechanical Bowel&#xD;
      Preparation (MBP) has been universally recognized as an effective measure to reduce colonic&#xD;
      bacterial load and consequently SSI rate, mostly in European Countries. However, in the early&#xD;
      1970s has been demonstrated a further SSI risk reduction in colon surgery if oral&#xD;
      non-absorbable antibiotics were added to MBP and for the next 30 years this became the&#xD;
      standard of care prior to elective colon surgery, especially in the US. Nowadays,&#xD;
      Meta-analyses have demonstrated that MBP does not impact upon postoperative morbidity or&#xD;
      mortality, and as such it should not be prescribed routinely. Conversely, recent evidence has&#xD;
      suggested that there may be a role for combined MBP and oral antibiotics, or oral antibiotics&#xD;
      alone in the prevention of surgical site infection (SSI).&#xD;
&#xD;
      The aim of this trial is to evaluate the efficacy of preoperative oral antibiotics&#xD;
      prophylaxis for preventing surgical site infections in elective colorectal surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a Multicenter, Prospective, Randomized, Controlled Trial on preoperative oral&#xD;
      antibiotics prophylaxis in colorectal surgery.&#xD;
&#xD;
      INCLUSION &amp; EXCLUSION CRITERIA:&#xD;
&#xD;
      All consecutive patients undergoing elective colorectal resection should be included in the&#xD;
      trial.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        -  Emergency procedures&#xD;
&#xD;
        -  Appendicectomy (unless procedure involves a right hemicolectomy)&#xD;
&#xD;
        -  Primarily urological/gynecological or vascular procedure - e.g. ileal conduit,&#xD;
           Hartmann's during ovarian surgery, resection during abdominal aortic aneurysm repair.&#xD;
&#xD;
        -  Diagnostic laparotomy/laparoscopy without intestinal resection.&#xD;
&#xD;
        -  Surgery involving multi-visceral surgery - e.g. pelvic exenteratio&#xD;
&#xD;
        -  Controindication for mechanical preparation&#xD;
&#xD;
        -  Allergy to used drugs&#xD;
&#xD;
        -  Patients who refuse to participate in the study&#xD;
&#xD;
        -  Patients with intra-abdominal sepsis before surgery (abscess).&#xD;
&#xD;
        -  Patients who received antibiotics for any reason within two weeks prior to surgery.&#xD;
&#xD;
        -  Patients who do not comply strictly with the assigned prophylaxis regimen.&#xD;
&#xD;
        -  Patients who cannot be followed at least 4 weeks after surgery.&#xD;
&#xD;
      Patients recruitment:&#xD;
&#xD;
      Consecutive eligible patients will be recruited at the outpatient clinic in the participating&#xD;
      center by the involved physician (surgeon). All patients fulfilling the inclusion criteria&#xD;
      will be informed about the study by the physician. After consent is given, central data&#xD;
      acquisition will take place web-based and patients will be randomized in 2 groups and treated&#xD;
      according to the study protocol. Patients unable or refusing to provide informed consent will&#xD;
      be treated according to current clinical practice.&#xD;
&#xD;
      Primary Outcome:&#xD;
&#xD;
      - Incidence of surgical site infections (superficial or deep)&#xD;
&#xD;
      Secondary Outcomes:&#xD;
&#xD;
        -  Perioperative complication&#xD;
&#xD;
        -  Anastomotic dehiscence&#xD;
&#xD;
        -  Post-operative ileus&#xD;
&#xD;
        -  Extra-abdominal complications&#xD;
&#xD;
        -  Readmission&#xD;
&#xD;
        -  Reoperation&#xD;
&#xD;
        -  Length of hospital stay&#xD;
&#xD;
        -  Mortality&#xD;
&#xD;
        -  Adverse effects of antibiotics (diarrhea, C. difficile infection)&#xD;
&#xD;
      Covariates:&#xD;
&#xD;
      In addition to demographic, procedure and outcome data, the following data will be collected&#xD;
      as confounding variables to permit accurate risk adjustment of outcomes.&#xD;
&#xD;
        -  The American Society of Anesthesiologists (ASA) score&#xD;
&#xD;
        -  Cardiovascular and metabolic co-morbidities (includes chronic obstructive pulmonary&#xD;
           disease (COPD), chronic kidney disease (CKD), peripheral vascular disease (PVD) and&#xD;
           diabetes mellitus)&#xD;
&#xD;
        -  History of previous abdominal surgery&#xD;
&#xD;
        -  Preoperative administration of immunosuppressive/steroid therapy&#xD;
&#xD;
        -  Preoperative Chemo-RadioTherapy&#xD;
&#xD;
        -  Preoperative Albumin Serum Level (g/dL)&#xD;
&#xD;
      Follow-up:&#xD;
&#xD;
        -  Patients will be followed for 30 days after surgery. All secondary outcome measures will&#xD;
           be recorded if they occurred at any point from post-operative day 0 (day of surgery) to&#xD;
           Day 30.&#xD;
&#xD;
        -  No change to normal follow-up should take place.&#xD;
&#xD;
        -  The follow-up of patients includes a clinical evaluation 30 days after surgical&#xD;
           intervention supported by blood analysis (WBC count and CRP), to completely exclude the&#xD;
           presence of any infectious complication. Presence of fever and/or WBC count/CRP&#xD;
           elevation will require further investigation with radiological imaging and will be&#xD;
           considered an infectious post operative complication (SSI or not).&#xD;
&#xD;
      PROJECT TIMELINE:&#xD;
&#xD;
      Data collection will take place in two years. Follow-up data will also be collected for up to&#xD;
      30 days after surgery.&#xD;
&#xD;
      Data Collection and Governance:&#xD;
&#xD;
      Data will be collected and stored online. Communication between the clients and the Server&#xD;
      where is hosted the online platform is secured under TLS protocol with an encryption&#xD;
      certificate SHA256 with RSA 2048 bits (e 65537). In order to maximize the data protection,&#xD;
      the physical HD where is sored the database is encrypted too. Access to the online platform&#xD;
      will be possible only previous Login. Each device logged in will be identified and the user&#xD;
      will be able to ban the access from a specific device. Each physician will be able to see and&#xD;
      modify only the data of patients added from his center. The online platform will check the&#xD;
      validity and the correct format of the fields and will generate an excel table to import to&#xD;
      the statistic software.&#xD;
&#xD;
      Intervention strategies:&#xD;
&#xD;
      Patients will be randomized to intravenous antibiotic prophylaxis alone or oral antibiotics&#xD;
      prepara-tion in association with intravenous antibiotic prophylaxis.&#xD;
&#xD;
      In the group of patients not treated with oral antibiotics standard intravenous prophylaxis&#xD;
      will be administered at the time of induction of anesthesia, redosing with prolonged surgery:&#xD;
      amoxicil-lin/clavulanic acid 2000/200 mg or, in the event of allergy to penicillin,&#xD;
      clindamycin 600 mg + gen-tamycin 2 mg/kg. In case of Chronic Renal Failure dose adjustment&#xD;
      will be necessary in presence of Creatinine Clearance respectively &lt;30 ml/min and &lt;60 ml/min&#xD;
      in accordance to pharmacologic recommendations.&#xD;
&#xD;
      In the other group oral prophylaxis consists of Bimixin (Neomicin + Bacitracin tablet) 25000&#xD;
      UI + 2500 UI). In the postoperative period no more doses will be administered because the&#xD;
      drug is not absorbed by gastrointestinal mucosa and its progression from the stomach to the&#xD;
      colon is slowed down by post-operative ileus. In this group of patient standard intravenous&#xD;
      antibiotic prophylaxis will be administered at induction of anesthesia.&#xD;
&#xD;
      Any mechanical bowel preparation will be administered, as indicated by each center. Surgeon,&#xD;
      anesthesiologist and nurse will know if patient had assumed oral antibiotics and intrave-nous&#xD;
      antibiotics or intravenous prophylaxis alone. Data concerning SSI rate, infectious&#xD;
      complica-tion other than SSI and not infectious complications will be collected during&#xD;
      hospital stay. 30 days after the operation blood tests (WBC, CRP) and clinical evaluation&#xD;
      will confirm the absence of any infectious complication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">November 1, 2021</completion_date>
  <primary_completion_date type="Actual">November 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wound infection</measure>
    <time_frame>up to 30 days after surgery</time_frame>
    <description>Incidence of surgical site infections (superficial or deep)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perioperative complication</measure>
    <time_frame>up to 30 days after surgery</time_frame>
    <description>Incidence of any preoperative complication, assessed as clinically detected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anastomotic dehiscence</measure>
    <time_frame>up to 30 days after surgery</time_frame>
    <description>Incidence of anastomotic dehiscence, assessed as clinically detected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative ileus</measure>
    <time_frame>up to 30 days after surgery</time_frame>
    <description>length of post-operative ileus, assessed as time to first flatus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extra-abdominal complications</measure>
    <time_frame>up to 30 days after surgery</time_frame>
    <description>Iatrogenic problems, bleeding, Cardiac- nephrological - respiratory and gastrointestinal complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission</measure>
    <time_frame>up to 30 days after surgery</time_frame>
    <description>incidence of readmission to hospital ward</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reoperation</measure>
    <time_frame>up to 30 days after surgery</time_frame>
    <description>incidence of reoperation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>up to 30 days after surgery</time_frame>
    <description>Hospital stay since colorectal surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>up to 30 days after surgery</time_frame>
    <description>incidence of death for any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Drug Reactions</measure>
    <time_frame>up to 30 days after surgery</time_frame>
    <description>Allergic reactions / Intolerance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Colorectal Surgery</condition>
  <arm_group>
    <arm_group_label>Oral + Parenteral prophylaxis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral antibiotic drugs:&#xD;
- Bimixin (Neomicin + Bacitracin tablet) 25000 UI + 2500 UI: h. 8-16-24 the day before surgery if the procedure takes place in the morning; h. 16-24-8 if the procedure takes place in the afternoon.&#xD;
Systemic antibiotic drugs:&#xD;
Amoxicillin - Clavulanic Acid 2000/200 mg at induction of anesthesia, redosing with prolonged surgery.&#xD;
in case of allergy to penicillin: Clindamycin 600 mg + Gentamycin 2 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Only parenteral prophylaxis</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Amoxicillin - Clavulanic Acid 2000/200 mg at induction of anesthesia, redosing with prolonged surgery.&#xD;
in case of allergy to penicillin: Clindamycin 600 mg + Gentamycin 2 mg/kg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral antibiotic drugs</intervention_name>
    <description>Oral antibiotic drugs:&#xD;
- Bimixin (Neomicin + Bacitracin tablet) 25000 UI + 2500 UI: h. 8-16-24 the day before surgery if the procedure takes place in the morning; h. 16-24-8 if the procedure takes place in the afternoon.</description>
    <arm_group_label>Oral + Parenteral prophylaxis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Parenteral prophylaxis</intervention_name>
    <description>Amoxicillin - Clavulanic Acid 2000/200 mg at induction of anesthesia, redosing with prolonged surgery.&#xD;
in case of allergy to penicillin: Clindamycin 600 mg + Gentamycin 2 mg/kg.</description>
    <arm_group_label>Only parenteral prophylaxis</arm_group_label>
    <arm_group_label>Oral + Parenteral prophylaxis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Summary: All consecutive patients undergoing colorectal resection should be included.&#xD;
&#xD;
          -  Age: Age 18 years or above.&#xD;
&#xD;
          -  The general health condition of the patient permits general anesthesia (ASA-&#xD;
             classification I-III).&#xD;
&#xD;
          -  Absence of allergy to the oral antibiotics employed&#xD;
&#xD;
          -  Timing: Elective procedures.&#xD;
&#xD;
          -  Technique: Open, laparoscopic, laparoscopic-assisted or laparoscopic converted to&#xD;
             open.&#xD;
&#xD;
          -  Returns to theatre: Each patient should only be included in the study once. Return to&#xD;
             theatre during the same admission or follow up should be collected as a complication.&#xD;
&#xD;
          -  Included procedures: Any colorectal resection (See Appendix B).&#xD;
&#xD;
          -  Mechanical Bowel Preparation: Any mechanical bowel preparation (as indicated by each&#xD;
             centre).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Emergency procedures&#xD;
&#xD;
          -  Appendicectomy (unless procedure involves a right hemicolectomy)&#xD;
&#xD;
          -  Primarily urological/gynecological or vascular procedure - e.g. ileal conduit,&#xD;
             Hartmann's during ovarian surgery, resection during abdominal aortic aneurysm repair.&#xD;
&#xD;
          -  Diagnostic laparotomy/laparoscopy without intestinal resection.&#xD;
&#xD;
          -  Surgery involving multi-visceral surgery - e.g. pelvic exenteratio&#xD;
&#xD;
          -  Controindication for mechanical preparation&#xD;
&#xD;
          -  Allergy to used drugs (neomycin sulfate, amoxicillin-clavulanic acid)&#xD;
&#xD;
          -  Patients who refuse to participate in the study&#xD;
&#xD;
          -  Patients with intra-abdominal sepsis before surgery (abscess).&#xD;
&#xD;
          -  Patients who received antibiotics for any reason within two weeks prior to surgery.&#xD;
&#xD;
          -  Patients who do not comply strictly with the assigned prophylaxis regimen.&#xD;
&#xD;
          -  Patients who cannot be followed at least 4 weeks after surgery.&#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>Alberto Arezzo, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Turin, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Università degli studi di Torino</name>
      <address>
        <city>Turin</city>
        <state>Torino</state>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>American College of Surgeons. National Surgical Quality Improvement Program Semi-annual report. 2009. Available at: https://acsnsqip.org/login/default.aspx.</citation>
  </reference>
  <reference>
    <citation>Arriaga AF, Lancaster RT, Berry WR, Regenbogen SE, Lipsitz SR, Kaafarani HM, Elbardissi AW, Desai P, Ferzoco SJ, Bleday R, Breen E, Kastrinakis WV, Rubin MS, Gawande AA. The better colectomy project: association of evidence-based best-practice adherence rates to outcomes in colorectal surgery. Ann Surg. 2009 Oct;250(4):507-13. doi: 10.1097/SLA.0b013e3181b672bc.</citation>
    <PMID>19734778</PMID>
  </reference>
  <reference>
    <citation>Csikesz NG, Nguyen LN, Tseng JF, Shah SA. Nationwide volume and mortality after elective surgery in cirrhotic patients. J Am Coll Surg. 2009 Jan;208(1):96-103. doi: 10.1016/j.jamcollsurg.2008.09.006. Epub 2008 Oct 31.</citation>
    <PMID>19228510</PMID>
  </reference>
  <reference>
    <citation>Finlayson EV, Goodney PP, Birkmeyer JD. Hospital volume and operative mortality in cancer surgery: a national study. Arch Surg. 2003 Jul;138(7):721-5; discussion 726. doi: 10.1001/archsurg.138.7.721.</citation>
    <PMID>12860752</PMID>
  </reference>
  <reference>
    <citation>Nichols RL, Broido P, Condon RE, Gorbach SL, Nyhus LM. Effect of preoperative neomycin-erythromycin intestinal preparation on the incidence of infectious complications following colon surgery. Ann Surg. 1973 Oct;178(4):453-62. doi: 10.1097/00000658-197310000-00008. No abstract available.</citation>
    <PMID>4743867</PMID>
  </reference>
  <reference>
    <citation>Slim K, Vicaut E, Launay-Savary MV, Contant C, Chipponi J. Updated systematic review and meta-analysis of randomized clinical trials on the role of mechanical bowel preparation before colorectal surgery. Ann Surg. 2009 Feb;249(2):203-9. doi: 10.1097/SLA.0b013e318193425a.</citation>
    <PMID>19212171</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>April 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>May 13, 2023</last_update_submitted>
  <last_update_submitted_qc>May 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turin, Italy</investigator_affiliation>
    <investigator_full_name>Alberto Arezzo</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04438655
org study id: Università di TORINO
nct id: NCT04438655
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Elective colon surgery is considered a clean-contaminated procedure, with a Surgical Site
      Infection (SSI) rate not inferior to 10%. For many years the role of Mechanical Bowel
      Preparation (MBP) has been universally recognized as an effective measure to reduce colonic
      bacterial load and consequently SSI rate, mostly in European Countries. However, in the early
      1970s has been demonstrated a further SSI risk reduction in colon surgery if oral
      non-absorbable antibiotics were added to MBP and for the next 30 years this became the
      standard of care prior to elective colon surgery, especially in the US. Nowadays,
      Meta-analyses have demonstrated that MBP does not impact upon postoperative morbidity or
      mortality, and as such it should not be prescribed routinely. Conversely, recent evidence has
      suggested that there may be a role for combined MBP and oral antibiotics, or oral antibiotics
      alone in the prevention of surgical site infection (SSI).

      The aim of this trial is to evaluate the efficacy of preoperative oral antibiotics
      prophylaxis for preventing surgical site infections in elective colorectal surgery.
This study is a Multicenter, Prospective, Randomized, Controlled Trial on preoperative oral
      antibiotics prophylaxis in colorectal surgery.

      INCLUSION & EXCLUSION CRITERIA:

      All consecutive patients undergoing elective colorectal resection should be included in the
      trial.

      Exclusion criteria:

        -  Emergency procedures

        -  Appendicectomy (unless procedure involves a right hemicolectomy)

        -  Primarily urological/gynecological or vascular procedure - e.g. ileal conduit,
           Hartmann's during ovarian surgery, resection during abdominal aortic aneurysm repair.

        -  Diagnostic laparotomy/laparoscopy without intestinal resection.

        -  Surgery involving multi-visceral surgery - e.g. pelvic exenteratio

        -  Controindication for mechanical preparation

        -  Allergy to used drugs

        -  Patients who refuse to participate in the study

        -  Patients with intra-abdominal sepsis before surgery (abscess).

        -  Patients who received antibiotics for any reason within two weeks prior to surgery.

        -  Patients who do not comply strictly with the assigned prophylaxis regimen.

        -  Patients who cannot be followed at least 4 weeks after surgery.

      Patients recruitment:

      Consecutive eligible patients will be recruited at the outpatient clinic in the participating
      center by the involved physician (surgeon). All patients fulfilling the inclusion criteria
      will be informed about the study by the physician. After consent is given, central data
      acquisition will take place web-based and patients will be randomized in 2 groups and treated
      according to the study protocol. Patients unable or refusing to provide informed consent will
      be treated according to current clinical practice.

      Primary Outcome:

      - Incidence of surgical site infections (superficial or deep)

      Secondary Outcomes:

        -  Perioperative complication

        -  Anastomotic dehiscence

        -  Post-operative ileus

        -  Extra-abdominal complications

        -  Readmission

        -  Reoperation

        -  Length of hospital stay

        -  Mortality

        -  Adverse effects of antibiotics (diarrhea, C. difficile infection)

      Covariates:

      In addition to demographic, procedure and outcome data, the following data will be collected
      as confounding variables to permit accurate risk adjustment of outcomes.

        -  The American Society of Anesthesiologists (ASA) score

        -  Cardiovascular and metabolic co-morbidities (includes chronic obstructive pulmonary
           disease (COPD), chronic kidney disease (CKD), peripheral vascular disease (PVD) and
           diabetes mellitus)

        -  History of previous abdominal surgery

        -  Preoperative administration of immunosuppressive/steroid therapy

        -  Preoperative Chemo-RadioTherapy

        -  Preoperative Albumin Serum Level (g/dL)

      Follow-up:

        -  Patients will be followed for 30 days after surgery. All secondary outcome measures will
           be recorded if they occurred at any point from post-operative day 0 (day of surgery) to
           Day 30.

        -  No change to normal follow-up should take place.

        -  The follow-up of patients includes a clinical evaluation 30 days after surgical
           intervention supported by blood analysis (WBC count and CRP), to completely exclude the
           presence of any infectious complication. Presence of fever and/or WBC count/CRP
           elevation will require further investigation with radiological imaging and will be
           considered an infectious post operative complication (SSI or not).

      PROJECT TIMELINE:

      Data collection will take place in two years. Follow-up data will also be collected for up to
      30 days after surgery.

      Data Collection and Governance:

      Data will be collected and stored online. Communication between the clients and the Server
      where is hosted the online platform is secured under TLS protocol with an encryption
      certificate SHA256 with RSA 2048 bits (e 65537). In order to maximize the data protection,
      the physical HD where is sored the database is encrypted too. Access to the online platform
      will be possible only previous Login. Each device logged in will be identified and the user
      will be able to ban the access from a specific device. Each physician will be able to see and
      modify only the data of patients added from his center. The online platform will check the
      validity and the correct format of the fields and will generate an excel table to import to
      the statistic software.

      Intervention strategies:

      Patients will be randomized to intravenous antibiotic prophylaxis alone or oral antibiotics
      prepara-tion in association with intravenous antibiotic prophylaxis.

      In the group of patients not treated with oral antibiotics standard intravenous prophylaxis
      will be administered at the time of induction of anesthesia, redosing with prolonged surgery:
      amoxicil-lin/clavulanic acid 2000/200 mg or, in the event of allergy to penicillin,
      clindamycin 600 mg + gen-tamycin 2 mg/kg. In case of Chronic Renal Failure dose adjustment
      will be necessary in presence of Creatinine Clearance respectively <30 ml/min and <60 ml/min
      in accordance to pharmacologic recommendations.

      In the other group oral prophylaxis consists of Bimixin (Neomicin + Bacitracin tablet) 25000
      UI + 2500 UI). In the postoperative period no more doses will be administered because the
      drug is not absorbed by gastrointestinal mucosa and its progression from the stomach to the
      colon is slowed down by post-operative ileus. In this group of patient standard intravenous
      antibiotic prophylaxis will be administered at induction of anesthesia.

      Any mechanical bowel preparation will be administered, as indicated by each center. Surgeon,
      anesthesiologist and nurse will know if patient had assumed oral antibiotics and intrave-nous
      antibiotics or intravenous prophylaxis alone. Data concerning SSI rate, infectious
      complica-tion other than SSI and not infectious complications will be collected during
      hospital stay. 30 days after the operation blood tests (WBC, CRP) and clinical evaluation
      will confirm the absence of any infectious complication.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Wound infection
time frame: up to 30 days after surgery
description: Incidence of surgical site infections (superficial or deep)
measure: Perioperative complication
time frame: up to 30 days after surgery
description: Incidence of any preoperative complication, assessed as clinically detected
measure: Anastomotic dehiscence
time frame: up to 30 days after surgery
description: Incidence of anastomotic dehiscence, assessed as clinically detected
measure: Post-operative ileus
time frame: up to 30 days after surgery
description: length of post-operative ileus, assessed as time to first flatus
measure: Extra-abdominal complications
time frame: up to 30 days after surgery
description: Iatrogenic problems, bleeding, Cardiac- nephrological - respiratory and gastrointestinal complications
measure: Readmission
time frame: up to 30 days after surgery
description: incidence of readmission to hospital ward
measure: Reoperation
time frame: up to 30 days after surgery
description: incidence of reoperation
measure: Length of hospital stay
time frame: up to 30 days after surgery
description: Hospital stay since colorectal surgery
measure: Mortality
time frame: up to 30 days after surgery
description: incidence of death for any cause
measure: Adverse Drug Reactions
time frame: up to 30 days after surgery
description: Allergic reactions / Intolerance
arm group label: Oral + Parenteral prophylaxis
arm group type: Experimental
description: Oral antibiotic drugs:
- Bimixin (Neomicin + Bacitracin tablet) 25000 UI + 2500 UI: h. 8-16-24 the day before surgery if the procedure takes place in the morning; h. 16-24-8 if the procedure takes place in the afternoon.
Systemic antibiotic drugs:
Amoxicillin - Clavulanic Acid 2000/200 mg at induction of anesthesia, redosing with prolonged surgery.
in case of allergy to penicillin: Clindamycin 600 mg + Gentamycin 2 mg/kg.
arm group label: Only parenteral prophylaxis
arm group type: Sham Comparator
description: Amoxicillin - Clavulanic Acid 2000/200 mg at induction of anesthesia, redosing with prolonged surgery.
in case of allergy to penicillin: Clindamycin 600 mg + Gentamycin 2 mg/kg.
intervention type: Drug
intervention name: Oral antibiotic drugs
description: Oral antibiotic drugs:
- Bimixin (Neomicin + Bacitracin tablet) 25000 UI + 2500 UI: h. 8-16-24 the day before surgery if the procedure takes place in the morning; h. 16-24-8 if the procedure takes place in the afternoon.
arm group label: Oral + Parenteral prophylaxis
intervention type: Drug
intervention name: Parenteral prophylaxis
description: Amoxicillin - Clavulanic Acid 2000/200 mg at induction of anesthesia, redosing with prolonged surgery.
in case of allergy to penicillin: Clindamycin 600 mg + Gentamycin 2 mg/kg.
arm group label: Only parenteral prophylaxis
arm group label: Oral + Parenteral prophylaxis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alberto Arezzo, Prof.
role: Principal Investigator
affiliation: University of Turin, Italy
facility: 
country: Italy
citation: American College of Surgeons. National Surgical Quality Improvement Program Semi-annual report. 2009. Available at: https://acsnsqip.org/login/default.aspx.
citation: Arriaga AF, Lancaster RT, Berry WR, Regenbogen SE, Lipsitz SR, Kaafarani HM, Elbardissi AW, Desai P, Ferzoco SJ, Bleday R, Breen E, Kastrinakis WV, Rubin MS, Gawande AA. The better colectomy project: association of evidence-based best-practice adherence rates to outcomes in colorectal surgery. Ann Surg. 2009 Oct;250(4):507-13. doi: 10.1097/SLA.0b013e3181b672bc.
PMID: 19734778
citation: Csikesz NG, Nguyen LN, Tseng JF, Shah SA. Nationwide volume and mortality after elective surgery in cirrhotic patients. J Am Coll Surg. 2009 Jan;208(1):96-103. doi: 10.1016/j.jamcollsurg.2008.09.006. Epub 2008 Oct 31.
PMID: 19228510
citation: Finlayson EV, Goodney PP, Birkmeyer JD. Hospital volume and operative mortality in cancer surgery: a national study. Arch Surg. 2003 Jul;138(7):721-5; discussion 726. doi: 10.1001/archsurg.138.7.721.
PMID: 12860752
citation: Nichols RL, Broido P, Condon RE, Gorbach SL, Nyhus LM. Effect of preoperative neomycin-erythromycin intestinal preparation on the incidence of infectious complications following colon surgery. Ann Surg. 1973 Oct;178(4):453-62. doi: 10.1097/00000658-197310000-00008. No abstract available.
PMID: 4743867
citation: Slim K, Vicaut E, Launay-Savary MV, Contant C, Chipponi J. Updated systematic review and meta-analysis of randomized clinical trials on the role of mechanical bowel preparation before colorectal surgery. Ann Surg. 2009 Feb;249(2):203-9. doi: 10.1097/SLA.0b013e318193425a.
PMID: 19212171
responsible party type: Principal Investigator
investigator affiliation: University of Turin, Italy
investigator full name: Alberto Arezzo
investigator title: Prof.
mesh term: Anti-Bacterial Agents
sharing ipd: No