<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/NCT03270930</url>
  </required_header>
  <id_info>
    <org_study_id>JNMCH</org_study_id>
    <nct_id>NCT03270930</nct_id>
  </id_info>
  <brief_title>Operative Duration as a Predictor of Mortality in Pediatric Emergency Surgery</brief_title>
  <official_title>A Prospective Study of Evaluation of Operative Duration as a Predictor of Mortality in Pediatric Emergency Surgery: Concept of 100 Minutes Laparotomy in Resource-limited Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jawaharlal Nehru Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jawaharlal Nehru Medical College</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>
      Introduction Operative duration is an important but under-studied predictor of mortality in&#xD;
      emergency laparotomies.&#xD;
&#xD;
      Aims &amp; Objectives The objective of this study was to quantify the effect of duration of&#xD;
      emergency laparotomy in children on mortality and to identify a rough cut-off duration of&#xD;
      laparotomy to serve as a guide to plan the laparotomy to optimize pediatric surgical patient&#xD;
      outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Operative duration has been found to affect post-operative mortality rates. Operative&#xD;
      duration has been studied in various studies as a risk factor for predicting morbidity and&#xD;
      several other post-operative complications like pneumonia. However, the direct effect of&#xD;
      operative duration on mortality has been studied sparingly and that too mainly in elective&#xD;
      setting and other authors. Thus, operative duration is an under-studied risk factor in&#xD;
      predicting mortality in emergency laparotomies. No study was found during literature review&#xD;
      which predicted mortality as a function of operative duration in emergency laparotomies. Most&#xD;
      studies focused on pre-operative factors and post-operative management for predicting&#xD;
      laparotomy outcomes like the use of POSSUM (Physiological and Operative Severity Score for&#xD;
      the enumeration of Mortality and morbidity) score. Thus, no clear-cut recommendation exists&#xD;
      regarding the optimal time duration for an emergency laparotomy in pediatric population&#xD;
      beyond which a laparotomy must not proceed as it would significantly increase the mortality&#xD;
      rate.&#xD;
&#xD;
      The primary objectives of the study were to quantify the effect of duration of emergency&#xD;
      laparotomy in children on mortality and to identify a rough cut-off duration of laparotomy to&#xD;
      serve as a guide so that such a laparotomy can be planned to optimize pediatric surgical&#xD;
      patient out come in terms of decreased mortality. The secondary objectives included&#xD;
      identifying factors that increase the time of emergency laparotomy and identifying measures&#xD;
      that could be applied to reduce the time of laparotomy significantly and improve outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2015</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2017</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>Effect of duration of laparotomy on pediatric post-operative mortality</measure>
    <time_frame>24 months</time_frame>
    <description>This study primarily quantified the effect of duration of emergency laparotomy in children on mortality and also identified a rough cut-off duration of laparotomy as 100 minutes that such a laparotomy can be planned to optimize pediatric surgical patient out come in terms of decreased mortality.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">213</enrollment>
  <condition>Mortality</condition>
  <condition>Pediatric</condition>
  <condition>Laparotomy</condition>
  <condition>Emergencies</condition>
  <arm_group>
    <arm_group_label>Survived</arm_group_label>
    <description>Pediatric patients in the age group of 5 to 10 years presenting with acute abdomen and undergoing emergency laparotomy who survived during their index 30-day hospital stay</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expired</arm_group_label>
    <description>Pediatric patients in the age group of 5 to 10 years presenting with acute abdomen and undergoing emergency laparotomy who expired during their index 30-day hospital stay</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Emergency laparotomy</intervention_name>
    <description>All patients in study underwent emergency laparotomy within 24 hours of presentation after adequate resuscitation of minimum 1 hour.</description>
    <arm_group_label>Expired</arm_group_label>
    <arm_group_label>Survived</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All pediatric patients presenting to our emergency department in the age group of 5 to 10&#xD;
        years presenting with acute abdomen diagnosed clinically and radiologically to be having a&#xD;
        diagnosis of secondary peritonitis and obstruction.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All pediatric patients in the age group of 5 to 10 years presenting with acute abdomen&#xD;
             diagnosed clinically and radiologically to be having a diagnosis of secondary&#xD;
             peritonitis and obstruction; who were adequately resuscitated (with a minimum&#xD;
             resuscitation period of at least 1 hour) pre-operatively and underwent definitive&#xD;
             surgery by a single surgeon (pediatric surgery senior resident) in the emergency were&#xD;
             included in the study. Also, only those patients who had a PRISM-III (Pediatric Risk&#xD;
             of Mortality III) score (Figure 1) of ≤ 8 at presentation were included to avoid the&#xD;
             confounding effect of pre-operative variables that might affect mortality. All&#xD;
             patients were adequately resuscitated in terms of temperature, central nervous system&#xD;
             (Glasgow Coma Scale, pupillary reflexes), cardiovascular system (systolic blood&#xD;
             pressure, heart rate) and respiratory system (oxygen saturation &gt; 95%, pCO2 , pH,&#xD;
             PaO2) parameters so that the patients were brought within 0 score range of PRISM-III&#xD;
             score at the end of resuscitation and before shifting to the operation theatre.&#xD;
             Furthermore for inclusion only those pediatric patients were considered who presented&#xD;
             within 72 hours of initial onset of symptoms, operated within 24 hours of initial&#xD;
             presentation and who died in index hospital admission within 30 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent damage control surgery, whose PRISM - III score was &gt;9 at any&#xD;
             point of time before undergoing laparotomy or inability to achieve adequate&#xD;
             resuscitation (PRISM-III score &gt;0 before shifting to operation theatre) and/or&#xD;
             requirement of resuscitation beyond 4 hours of presentation were excluded from the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kaushal D Singh, MS Surgery</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jawaharlal Nehru Medical College, Aligarh</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jawaharlal Nehru Medical College</investigator_affiliation>
    <investigator_full_name>Kaushal Deep Singh</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Operative duration</keyword>
  <keyword>Pediatric surgery</keyword>
  <keyword>Emergency laparotomy</keyword>
  <keyword>Mortality rate</keyword>
  <keyword>Survival</keyword>
  <keyword>Kaplan-Meier analysis</keyword>
  <keyword>ROC curve analysis</keyword>
  <keyword>Senior resident</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All the statistics of the patients like age, sex, operative duration, PRISM-III scores, duration of transfer to operation theatre and the final outcome will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be available in the next 6 months and will be available for unlimited period of time</ipd_time_frame>
    <ipd_access_criteria>Anyone can access the data here</ipd_access_criteria>
    <ipd_url>https://www.researchgate.net/project/Effect-of-Paediatric-Laparotomy-Operative-Duration-on-Mortality-in-Emergency-Surgeries</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 31, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03270930/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 31, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03270930/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 31, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03270930/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03270930
org study id: JNMCH
nct id: NCT03270930
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Introduction Operative duration is an important but under-studied predictor of mortality in
      emergency laparotomies.

      Aims & Objectives The objective of this study was to quantify the effect of duration of
      emergency laparotomy in children on mortality and to identify a rough cut-off duration of
      laparotomy to serve as a guide to plan the laparotomy to optimize pediatric surgical patient
      outcome.
Operative duration has been found to affect post-operative mortality rates. Operative
      duration has been studied in various studies as a risk factor for predicting morbidity and
      several other post-operative complications like pneumonia. However, the direct effect of
      operative duration on mortality has been studied sparingly and that too mainly in elective
      setting and other authors. Thus, operative duration is an under-studied risk factor in
      predicting mortality in emergency laparotomies. No study was found during literature review
      which predicted mortality as a function of operative duration in emergency laparotomies. Most
      studies focused on pre-operative factors and post-operative management for predicting
      laparotomy outcomes like the use of POSSUM (Physiological and Operative Severity Score for
      the enumeration of Mortality and morbidity) score. Thus, no clear-cut recommendation exists
      regarding the optimal time duration for an emergency laparotomy in pediatric population
      beyond which a laparotomy must not proceed as it would significantly increase the mortality
      rate.

      The primary objectives of the study were to quantify the effect of duration of emergency
      laparotomy in children on mortality and to identify a rough cut-off duration of laparotomy to
      serve as a guide so that such a laparotomy can be planned to optimize pediatric surgical
      patient out come in terms of decreased mortality. The secondary objectives included
      identifying factors that increase the time of emergency laparotomy and identifying measures
      that could be applied to reduce the time of laparotomy significantly and improve outcome.
observational model: Cohort
time perspective: Prospective
measure: Effect of duration of laparotomy on pediatric post-operative mortality
time frame: 24 months
description: This study primarily quantified the effect of duration of emergency laparotomy in children on mortality and also identified a rough cut-off duration of laparotomy as 100 minutes that such a laparotomy can be planned to optimize pediatric surgical patient out come in terms of decreased mortality.
arm group label: Survived
description: Pediatric patients in the age group of 5 to 10 years presenting with acute abdomen and undergoing emergency laparotomy who survived during their index 30-day hospital stay
arm group label: Expired
description: Pediatric patients in the age group of 5 to 10 years presenting with acute abdomen and undergoing emergency laparotomy who expired during their index 30-day hospital stay
intervention type: Procedure
intervention name: Emergency laparotomy
description: All patients in study underwent emergency laparotomy within 24 hours of presentation after adequate resuscitation of minimum 1 hour.
arm group label: Expired
arm group label: Survived
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 10 Years
healthy volunteers: No
last name: Kaushal D Singh, MS Surgery
role: Principal Investigator
affiliation: Jawaharlal Nehru Medical College, Aligarh
responsible party type: Principal Investigator
investigator affiliation: Jawaharlal Nehru Medical College
investigator full name: Kaushal Deep Singh
investigator title: Principal Investigator
mesh term: Emergencies
sharing ipd: Yes
ipd description: All the statistics of the patients like age, sex, operative duration, PRISM-III scores, duration of transfer to operation theatre and the final outcome will be shared.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be available in the next 6 months and will be available for unlimited period of time
ipd access criteria: Anyone can access the data here
ipd url: https://www.researchgate.net/project/Effect-of-Paediatric-Laparotomy-Operative-Duration-on-Mortality-in-Emergency-Surgeries
provided document: 
provided document: 
provided document: 