<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/NCT04448912</url>
  </required_header>
  <id_info>
    <org_study_id>SRMA non-trauma DCS</org_study_id>
    <nct_id>NCT04448912</nct_id>
  </id_info>
  <brief_title>Meta-Analysis on Damage Control Surgery in Patients With Non-Traumatic Abdominal Emergencies</brief_title>
  <official_title>Damage-Control Surgery in Patients With Non-traumatic Abdominal Emergencies: A Systematic Review and Meta-Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</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>
      This systematic review and meta-analysis aims to investigate the effect of damage-control&#xD;
      surgery on mortality in patients with non-traumatic abdominal emergencies. Literature search&#xD;
      will be conducted using PubMed. Two meta-analyses will be performed comparing (1) mortality&#xD;
      in patients with non-trauma damage control surgery vs. non-trauma conventional surgery and&#xD;
      (2) the observed vs. expected mortality rate in patients undergoing non-trauma damage-control&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After the successful implementation in trauma patients, damage control surgery (DCS) is being&#xD;
      increasingly used in patients with non-traumatic abdominal emergencies, too. However,&#xD;
      non-trauma DCS is an ongoing matter of debate as the open abdomen treatment typically&#xD;
      performed in DCS is a non-anatomical situation and associated with potentially severe side&#xD;
      effects. To date, DCS in patients with non-traumatic abdominal emergencies has not yet been&#xD;
      comprehensively assessed in meta-analysis.&#xD;
&#xD;
      A systematic literature search will be conducted using the National Library of Medicine's&#xD;
      Medline database (PubMed). The search strategy will be based on the PICOS process. Original&#xD;
      research articles in English language addressing (1) mortality in patients undergoing&#xD;
      non-trauma DCS vs. non-trauma conventional surgery or (2) the observed vs. expected mortality&#xD;
      in non-trauma DCS will be included.&#xD;
&#xD;
      Two meta-analyses will be performed, comparing (1) mortality in patients undergoing&#xD;
      non-trauma DCS vs. non-trauma conventional surgery and (2) the observed vs. expected&#xD;
      mortality rate in patients undergoing non-trauma DCS based on outcome prediction scores.&#xD;
      Meta-analysis will be performed using a random-effects model. The estimated effect size for&#xD;
      mortality will be reported as risk difference with 95% confidence intervals. Sensitivity&#xD;
      analysis will be performed by repeating the analysis in the subgroups of studies with the&#xD;
      same study design and studies that applied the same outcome prediction score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2018</start_date>
  <completion_date type="Actual">April 24, 2021</completion_date>
  <primary_completion_date type="Actual">April 24, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>From hospital admission to discharge, expected to be up to 4 weeks</time_frame>
    <description>Death after surgery for non-traumatic abdominal emergencies</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2170</enrollment>
  <condition>Damage Control Surgery</condition>
  <condition>Non-traumatic Abdominal Emergencies</condition>
  <arm_group>
    <arm_group_label>Non-trauma damge control surgery</arm_group_label>
    <description>Patients with non-traumatic abdominal emergencies undergoing damage control surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-trauma conventional surgery</arm_group_label>
    <description>Patients with non-traumatic abdominal emergencies undergoing conventional surgery with primary abdominal closure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Damage control surgery</intervention_name>
    <description>Surgery for non-traumatic abdominal emergencies using the damage control approach</description>
    <arm_group_label>Non-trauma damge control surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional surgery</intervention_name>
    <description>Conventional surgery for non-traumatic abdominal emergencies</description>
    <arm_group_label>Non-trauma conventional surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing surgery for non-traumatic abdominal emergencies.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Articles on damage control surgery in patients with non-traumatic abdominal&#xD;
             emergencies&#xD;
&#xD;
          -  Reported in-hospital or 30-day mortality in patients undergoing non-trauma damage&#xD;
             control surgery vs non-trauma conventional surgery or&#xD;
&#xD;
          -  Reported observed in-hospital or 30-day mortality vs expected mortality in patients&#xD;
             undergoing non-trauma damage control surgery&#xD;
&#xD;
          -  Articles published from 2000 to 2020&#xD;
&#xD;
          -  Articles including patients older than 18 years&#xD;
&#xD;
          -  Original research articles&#xD;
&#xD;
          -  Articles in English language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Articles describing trauma patients exclusively&#xD;
&#xD;
          -  Articles describing pediatric patients (age below or equal to 18 years)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tobias Haltmeier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inselspital, Bern University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inselspital, Bern University Hospial</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_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/NCT04448912
org study id: SRMA non-trauma DCS
nct id: NCT04448912
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This systematic review and meta-analysis aims to investigate the effect of damage-control
      surgery on mortality in patients with non-traumatic abdominal emergencies. Literature search
      will be conducted using PubMed. Two meta-analyses will be performed comparing (1) mortality
      in patients with non-trauma damage control surgery vs. non-trauma conventional surgery and
      (2) the observed vs. expected mortality rate in patients undergoing non-trauma damage-control
      surgery.
After the successful implementation in trauma patients, damage control surgery (DCS) is being
      increasingly used in patients with non-traumatic abdominal emergencies, too. However,
      non-trauma DCS is an ongoing matter of debate as the open abdomen treatment typically
      performed in DCS is a non-anatomical situation and associated with potentially severe side
      effects. To date, DCS in patients with non-traumatic abdominal emergencies has not yet been
      comprehensively assessed in meta-analysis.

      A systematic literature search will be conducted using the National Library of Medicine's
      Medline database (PubMed). The search strategy will be based on the PICOS process. Original
      research articles in English language addressing (1) mortality in patients undergoing
      non-trauma DCS vs. non-trauma conventional surgery or (2) the observed vs. expected mortality
      in non-trauma DCS will be included.

      Two meta-analyses will be performed, comparing (1) mortality in patients undergoing
      non-trauma DCS vs. non-trauma conventional surgery and (2) the observed vs. expected
      mortality rate in patients undergoing non-trauma DCS based on outcome prediction scores.
      Meta-analysis will be performed using a random-effects model. The estimated effect size for
      mortality will be reported as risk difference with 95% confidence intervals. Sensitivity
      analysis will be performed by repeating the analysis in the subgroups of studies with the
      same study design and studies that applied the same outcome prediction score.
observational model: Other
time perspective: Retrospective
measure: Mortality
time frame: From hospital admission to discharge, expected to be up to 4 weeks
description: Death after surgery for non-traumatic abdominal emergencies
arm group label: Non-trauma damge control surgery
description: Patients with non-traumatic abdominal emergencies undergoing damage control surgery.
arm group label: Non-trauma conventional surgery
description: Patients with non-traumatic abdominal emergencies undergoing conventional surgery with primary abdominal closure.
intervention type: Procedure
intervention name: Damage control surgery
description: Surgery for non-traumatic abdominal emergencies using the damage control approach
arm group label: Non-trauma damge control surgery
intervention type: Procedure
intervention name: Conventional surgery
description: Conventional surgery for non-traumatic abdominal emergencies
arm group label: Non-trauma conventional surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Tobias Haltmeier, MD
role: Principal Investigator
affiliation: Inselspital, Bern University Hospital
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Emergencies
sharing ipd: No