<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/NCT03262025</url>
  </required_header>
  <id_info>
    <org_study_id>CecalJNMC</org_study_id>
    <nct_id>NCT03262025</nct_id>
  </id_info>
  <brief_title>Primary Cecal Pathologies Presenting as Acute Abdomen</brief_title>
  <official_title>Primary Cecal Pathologies Presenting as Acute Abdomen and Critical Appraisal of Their Current Management Strategies</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>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>
      Background: The importance of cecal pathologies lie in the fact that being the first part of&#xD;
      large intestine, any disease involving the cecum affects overall functioning of the large&#xD;
      bowel. Primary cecal pathologies presenting as acute abdomen have not been described in any&#xD;
      previous study in terms of presentation, management and outcome.&#xD;
&#xD;
      Objectives: The objective of this study was to identify the reported causes of primary cecal&#xD;
      pathologies presenting as acute abdomen and the various causes presenting in Indian setting,&#xD;
      to discuss morbidity and mortality associated with cecal pathologies and to critically&#xD;
      analyse the various management modalities employed in emergency setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The importance of cecal pathologies lie in the fact that being the first part of large&#xD;
      intestine, any disease involving the cecum affects overall functioning of the large bowel.&#xD;
      Primary cecal pathologies presenting as acute abdomen often pose a challenge to their optimal&#xD;
      management due to requirement of urgent intervention in most cases and being a common source&#xD;
      of misdiagnosis. These pathologies often mimic acute appendicitis and commonly misdiagnosed&#xD;
      as one. This misdiagnosis can lead to under-treatment of the underlying pathology and this&#xD;
      results in high morbidity and mortality associated with these conditions. So the accurate&#xD;
      identification of such conditions is required so that the patients can be optimally managed&#xD;
      and patient outcome can be improved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">July 15, 2017</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pattern of primary cecal pathology in Indian setting</measure>
    <time_frame>10 years</time_frame>
    <description>The objective of this study was to identify the reported causes of cecal pathology presenting as acute abdomen in medical literature and the various causes presenting in Indian setting, to identify the pattern of common pathologies in Indian setup, to discuss morbidity and mortality associated with cecal pathologies and to critically analyse the various management modalities commonly employed for cecal pathologies presenting as acute abdomen.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">43</enrollment>
  <condition>Acute Abdomen</condition>
  <condition>Emergency Surgery</condition>
  <condition>Laparotomy</condition>
  <condition>Amoebic Colitis</condition>
  <condition>Diverticulitis of Caecum</condition>
  <condition>Typhlitis</condition>
  <arm_group>
    <arm_group_label>Operated patients who survived</arm_group_label>
    <description>Patients who were discharged in index hospital admission after operative intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Operated patients who expired</arm_group_label>
    <description>Patients who expired in index hospital admission after operative intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-operated patients who survived</arm_group_label>
    <description>Patients who were discharged in index hospital admission after being managed conservatively</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-operated patients who expired</arm_group_label>
    <description>Patients who expired in index hospital admission after being managed conservatively</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Operated</intervention_name>
    <description>Patients were either managed conservatively or underwent emergency laparotomy</description>
    <arm_group_label>Operated patients who expired</arm_group_label>
    <arm_group_label>Operated patients who survived</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients presenting in the emergency department with acute abdomen were included&#xD;
        in study in whom cecal pathology as the cause of acute abdomen was suspected clinically&#xD;
        and/or on imaging and further confirmed per-operatively and/or on histopathological&#xD;
        examination (HPE) or on imaging.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients presenting in emergency department with acute abdomen were included&#xD;
             in study in whom cecal pathology as the cause of acute abdomen was suspected&#xD;
             clinically and/or on imaging and further confirmed per-operatively and/or on&#xD;
             histopathological examination (HPE) or on imaging. Patients identified with primarily&#xD;
             a cecal pathology who had acute pain abdomen as the initial symptom but who didn't&#xD;
             presented immediately due to various reasons were also included in the study as it is&#xD;
             a well-documented fact that patients in developing countries like India, especially&#xD;
             those who live in rural areas or who are illiterate often resort to indigenous methods&#xD;
             of treatment or take symptomatic treatment from local practitioners before presenting&#xD;
             to a tertiary centre for definitive treatment. Also, only those patients who were&#xD;
             operated within 24 hours of index admission in the emergency operation theatre (EOT)&#xD;
             by a registrar or faculty member after initial resuscitation were included in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with sub-acute, intermittent or chronic pain; when predominant symptoms were&#xD;
             attributable to some other cause even with concomitant presence of a cecal pathology;&#xD;
             when predominant pathology was not cecal and patients with cecal pathology operated as&#xD;
             an elective case were excluded from this study. Thus patients diagnosed to be having&#xD;
             appendiceal stump blowout, perforation of base of appendix, ileocecal tuberculosis or&#xD;
             intussusception were not included.&#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>Kaushal D Singh, MS Surgery</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jawaharlal Nehru Medical College, Aligarh</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 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>Primary cecal pathology</keyword>
  <keyword>Emergency laparotomy</keyword>
  <keyword>Ruptured liver abscess</keyword>
  <keyword>Right hemicolectomy</keyword>
  <keyword>Conservative colonic resection</keyword>
  <keyword>Fulminant amoebic colitis</keyword>
  <keyword>Ileocecal resection</keyword>
  <keyword>Ileoascending anastomosis</keyword>
  <keyword>Ileotransverse anastomosis</keyword>
  <keyword>Cecal diverticulitis</keyword>
  <keyword>Amoebic typhilitis</keyword>
  <keyword>Idiopathic typhilitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysentery, Amebic</mesh_term>
    <mesh_term>Amebiasis</mesh_term>
    <mesh_term>Typhlitis</mesh_term>
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Diverticulitis</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Abdomen, Acute</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data can be shared on request for multi-institutional prospective studies.</ipd_description>
  </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>January 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03262025/Prot_000.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>January 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03262025/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>August 26, 2017</submitted>
    <returned>September 25, 2017</returned>
  </pending_results>
  <!-- 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/NCT03262025
org study id: CecalJNMC
nct id: NCT03262025
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: The importance of cecal pathologies lie in the fact that being the first part of
      large intestine, any disease involving the cecum affects overall functioning of the large
      bowel. Primary cecal pathologies presenting as acute abdomen have not been described in any
      previous study in terms of presentation, management and outcome.

      Objectives: The objective of this study was to identify the reported causes of primary cecal
      pathologies presenting as acute abdomen and the various causes presenting in Indian setting,
      to discuss morbidity and mortality associated with cecal pathologies and to critically
      analyse the various management modalities employed in emergency setting.
The importance of cecal pathologies lie in the fact that being the first part of large
      intestine, any disease involving the cecum affects overall functioning of the large bowel.
      Primary cecal pathologies presenting as acute abdomen often pose a challenge to their optimal
      management due to requirement of urgent intervention in most cases and being a common source
      of misdiagnosis. These pathologies often mimic acute appendicitis and commonly misdiagnosed
      as one. This misdiagnosis can lead to under-treatment of the underlying pathology and this
      results in high morbidity and mortality associated with these conditions. So the accurate
      identification of such conditions is required so that the patients can be optimally managed
      and patient outcome can be improved.
observational model: Case-Only
time perspective: Retrospective
measure: Pattern of primary cecal pathology in Indian setting
time frame: 10 years
description: The objective of this study was to identify the reported causes of cecal pathology presenting as acute abdomen in medical literature and the various causes presenting in Indian setting, to identify the pattern of common pathologies in Indian setup, to discuss morbidity and mortality associated with cecal pathologies and to critically analyse the various management modalities commonly employed for cecal pathologies presenting as acute abdomen.
arm group label: Operated patients who survived
description: Patients who were discharged in index hospital admission after operative intervention
arm group label: Operated patients who expired
description: Patients who expired in index hospital admission after operative intervention
arm group label: Non-operated patients who survived
description: Patients who were discharged in index hospital admission after being managed conservatively
arm group label: Non-operated patients who expired
description: Patients who expired in index hospital admission after being managed conservatively
intervention type: Procedure
intervention name: Operated
description: Patients were either managed conservatively or underwent emergency laparotomy
arm group label: Operated patients who expired
arm group label: Operated patients who survived
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
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: Dysentery, Amebic
mesh term: Amebiasis
mesh term: Typhlitis
mesh term: Colitis
mesh term: Diverticulitis
mesh term: Emergencies
mesh term: Abdomen, Acute
sharing ipd: Undecided
ipd description: Data can be shared on request for multi-institutional prospective studies.
provided document: 
provided document: 
submitted: August 26, 2017
returned: September 25, 2017