<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/NCT02229695</url>
  </required_header>
  <id_info>
    <org_study_id>SOR-0167-14</org_study_id>
    <nct_id>NCT02229695</nct_id>
  </id_info>
  <brief_title>The Effect of Different Types of Temporary Abdominal Closure on Intra Abdominal Hypertension.</brief_title>
  <acronym>TACACS</acronym>
  <official_title>The Effect of Different Types of Temporary Abdominal Closure on Intra Abdominal Hypertension and Abdominal Compartment Syndrome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soroka University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Soroka University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective comparison trial. Patients that will be included in the trial are those&#xD;
      that will have operations in which their abdominal closure is temporary, i.e. patients&#xD;
      sustaining trauma or septic abdomen.&#xD;
&#xD;
      Patients will be grouped according to the method of temporarily abdominal closure (TAC)&#xD;
      procedure:&#xD;
&#xD;
        1. Vacuum-assisted closure (VAC)&#xD;
&#xD;
        2. &quot;Bogota bag&quot; (BB), a sterile intravenous bag silo closure. The two methods are currently&#xD;
           accepted with no clear cut evidence to prefer one on another. At Soroka Medical Center&#xD;
           the decision to choose either of the methods is at the surgeon's discretion.&#xD;
&#xD;
      Intra-abdominal pressure will be measured in all patients by the urinary bladder pressure&#xD;
      technique at 6 12 24 ant 48 hours post operation. The measurement is a routine procedure done&#xD;
      as part of the monitoring processes of critically ill patients in the General Intensive Care&#xD;
      Unit (GICU).&#xD;
&#xD;
      Patients will be evaluated for the development of acute intra abdominal hypertension with or&#xD;
      without abdominal compartment syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparison of intra-Abdominal hypertension development after bogota bag or VAC abdominal&#xD;
      closure Protocol&#xD;
&#xD;
      Trial objective:&#xD;
&#xD;
      To investigate and compare in a standardized manner the development of intra-abdominal&#xD;
      hypertension (IAH) following VAC closure and &quot;Bogota bag&quot;.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      This is a prospective comparison trial. Patients that will be included in the trial are those&#xD;
      that will have operations in which their abdominal closure is temporary, i.e. patients&#xD;
      sustaining trauma or septic abdomen.&#xD;
&#xD;
      Patients will be grouped according to the method of temporarily abdominal closure (TAC)&#xD;
      procedure:&#xD;
&#xD;
        1. VAC closure&#xD;
&#xD;
        2. &quot;Bogota bag&quot; (BB), a sterile intravenous bag silo closure. The two methods are currently&#xD;
           accepted with no clear cut evidence to prefer one on another. At Soroka Medical Center&#xD;
           the decision to choose either of the methods is at the surgeon's discretion.&#xD;
&#xD;
      Intra-abdominal pressure will be measured in all patients by the urinary bladder pressure&#xD;
      technique at 6 12 24 ant 48 hours post operation. The measurement is a routine procedure done&#xD;
      as part of the monitoring processes of critically ill patients in the GICU. It will be&#xD;
      carried out by a nurse who will be blinded as to the type of the abdominal closure.&#xD;
&#xD;
      Patients will be evaluated for the development of acute and significant respiratory&#xD;
      compromise, including an elevated inspiratory pressure of &gt;35 mbar and a decreased partial&#xD;
      oxygen pressure / fraction of inspired oxygen (PaO2/FIO2) of &lt;150 torr, hypotension (&lt;90 mmHg&#xD;
      systolic pressure not due to hemorrhagic, septic, or neurogenic causes), renal dysfunction&#xD;
      (urine output, &lt;30 mL/hr), and a clinically determined rigid, tense abdomen, and increased&#xD;
      abdominal circumference.&#xD;
&#xD;
      The following data will be recorded. Hemodynamics (mean arterial pressure, heart rate),&#xD;
      lactate, PaO2, partial carbonic dioxide pressure (PaCO2), tidal volume, peak airway pressure)&#xD;
      and renal (urine output) functions will be registered at 24 and 48 hours following surgery).&#xD;
&#xD;
      Data on the indication for operation, type of trauma, its severity and the operative&#xD;
      procedures.&#xD;
&#xD;
      Acute Physiologic and Chronic Health Evaluation II (APACHE II) and fluid balance at 24 and 48&#xD;
      hours.&#xD;
&#xD;
      Reoperations. Time in ICU and time to final abdominal closure.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      All patients with severe abdominal trauma or none traumatic acute abdomen, that at the end of&#xD;
      operation the surgeon will decide to use temporary abdominal closure (TAC).&#xD;
&#xD;
      Inclusion Criteria Adults male or female over 18 years old. The surgeon decides the need for&#xD;
      TAC at the end of operation.&#xD;
&#xD;
      Exclusion Criteria Patients that the surgeon estimates they will not survive 24 hours.&#xD;
&#xD;
      End points:&#xD;
&#xD;
      Development of IAH Development of abdominal compartment syndrome (ACS) Need for reoperation&#xD;
      of decompressive laparotomy during first 48 hours. Time to final (on discharge from hospital)&#xD;
      abdominal closure and the type of closure.&#xD;
&#xD;
      Statistical methodology The calculated sample size based on power of 0.80, alpha 0.05, known&#xD;
      incidence of 0.25 and estimated incidence of 0.10 is 42 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Intra abdominal hypertension</measure>
    <time_frame>48 hours</time_frame>
    <description>measured via a Foley catheter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Abdominal compartment syndrome</measure>
    <time_frame>48 hours</time_frame>
    <description>According to clinical signs (hypotension, increased inspiratory pressure, decreased urinary output).</description>
  </secondary_outcome>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Intra Abdominal Hypertension</condition>
  <condition>Abdominal Compartment Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients that undergo emergent laparotomy for trauma or non-traumatic surgical emergency&#xD;
        condition, and that according to the surgeon decision get their abdominal wall closed by a&#xD;
        temporary closure technique.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults male or female over 18 year old undergoing emergency laparotomy. Patients that&#xD;
             have their abdominal wall closed at the end of surgery by a temporary closure&#xD;
             technique.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that according to the surgeon estimates will not survive 24 hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gad Shaked, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Soroka University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gad Shaked</last_name>
    <email>shakedg@bgu.ac.il</email>
  </overall_contact>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>August 28, 2014</last_update_submitted>
  <last_update_submitted_qc>August 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Soroka University Medical Center</investigator_affiliation>
    <investigator_full_name>Gad Shaked MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Trauma</keyword>
  <keyword>Sepsis</keyword>
  <keyword>Temporary abdominal closure</keyword>
  <keyword>Bogota bag</keyword>
  <keyword>Vacuum assisted closure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compartment Syndromes</mesh_term>
    <mesh_term>Intra-Abdominal Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT02229695
org study id: SOR-0167-14
nct id: NCT02229695
lead sponsor: 
has dmc: No
This is a prospective comparison trial. Patients that will be included in the trial are those
      that will have operations in which their abdominal closure is temporary, i.e. patients
      sustaining trauma or septic abdomen.

      Patients will be grouped according to the method of temporarily abdominal closure (TAC)
      procedure:

        1. Vacuum-assisted closure (VAC)

        2. "Bogota bag" (BB), a sterile intravenous bag silo closure. The two methods are currently
           accepted with no clear cut evidence to prefer one on another. At Soroka Medical Center
           the decision to choose either of the methods is at the surgeon's discretion.

      Intra-abdominal pressure will be measured in all patients by the urinary bladder pressure
      technique at 6 12 24 ant 48 hours post operation. The measurement is a routine procedure done
      as part of the monitoring processes of critically ill patients in the General Intensive Care
      Unit (GICU).

      Patients will be evaluated for the development of acute intra abdominal hypertension with or
      without abdominal compartment syndrome.
Comparison of intra-Abdominal hypertension development after bogota bag or VAC abdominal
      closure Protocol

      Trial objective:

      To investigate and compare in a standardized manner the development of intra-abdominal
      hypertension (IAH) following VAC closure and "Bogota bag".

      Study design:

      This is a prospective comparison trial. Patients that will be included in the trial are those
      that will have operations in which their abdominal closure is temporary, i.e. patients
      sustaining trauma or septic abdomen.

      Patients will be grouped according to the method of temporarily abdominal closure (TAC)
      procedure:

        1. VAC closure

        2. "Bogota bag" (BB), a sterile intravenous bag silo closure. The two methods are currently
           accepted with no clear cut evidence to prefer one on another. At Soroka Medical Center
           the decision to choose either of the methods is at the surgeon's discretion.

      Intra-abdominal pressure will be measured in all patients by the urinary bladder pressure
      technique at 6 12 24 ant 48 hours post operation. The measurement is a routine procedure done
      as part of the monitoring processes of critically ill patients in the GICU. It will be
      carried out by a nurse who will be blinded as to the type of the abdominal closure.

      Patients will be evaluated for the development of acute and significant respiratory
      compromise, including an elevated inspiratory pressure of >35 mbar and a decreased partial
      oxygen pressure / fraction of inspired oxygen (PaO2/FIO2) of <150 torr, hypotension (<90 mmHg
      systolic pressure not due to hemorrhagic, septic, or neurogenic causes), renal dysfunction
      (urine output, <30 mL/hr), and a clinically determined rigid, tense abdomen, and increased
      abdominal circumference.

      The following data will be recorded. Hemodynamics (mean arterial pressure, heart rate),
      lactate, PaO2, partial carbonic dioxide pressure (PaCO2), tidal volume, peak airway pressure)
      and renal (urine output) functions will be registered at 24 and 48 hours following surgery).

      Data on the indication for operation, type of trauma, its severity and the operative
      procedures.

      Acute Physiologic and Chronic Health Evaluation II (APACHE II) and fluid balance at 24 and 48
      hours.

      Reoperations. Time in ICU and time to final abdominal closure.

      Study population:

      All patients with severe abdominal trauma or none traumatic acute abdomen, that at the end of
      operation the surgeon will decide to use temporary abdominal closure (TAC).

      Inclusion Criteria Adults male or female over 18 years old. The surgeon decides the need for
      TAC at the end of operation.

      Exclusion Criteria Patients that the surgeon estimates they will not survive 24 hours.

      End points:

      Development of IAH Development of abdominal compartment syndrome (ACS) Need for reoperation
      of decompressive laparotomy during first 48 hours. Time to final (on discharge from hospital)
      abdominal closure and the type of closure.

      Statistical methodology The calculated sample size based on power of 0.80, alpha 0.05, known
      incidence of 0.25 and estimated incidence of 0.10 is 42 patients.
observational model: Cohort
time perspective: Prospective
measure: Intra abdominal hypertension
time frame: 48 hours
description: measured via a Foley catheter
measure: Abdominal compartment syndrome
time frame: 48 hours
description: According to clinical signs (hypotension, increased inspiratory pressure, decreased urinary output).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Gad Shaked, Prof.
role: Principal Investigator
affiliation: Soroka University Medical Center
last name: Gad Shaked
email: shakedg@bgu.ac.il
responsible party type: Principal Investigator
investigator affiliation: Soroka University Medical Center
investigator full name: Gad Shaked MD
investigator title: Professor
mesh term: Compartment Syndromes
mesh term: Intra-Abdominal Hypertension
mesh term: Hypertension
mesh term: Syndrome