<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/NCT04427891</url>
  </required_header>
  <id_info>
    <org_study_id>2019-06114</org_study_id>
    <nct_id>NCT04427891</nct_id>
  </id_info>
  <brief_title>Characteristics of Abdominal Fluid in Patients With Diverticulitis Hinchey III or IV</brief_title>
  <official_title>Study of Changes in Abdominal Fluid in Connection With Peritonitis. A Descriptive Study in Patients With Purulent or Fecal Peritonitis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</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>
      Perforated diverticulitis of the colon can be complicated by peritonitis, either purulent or&#xD;
      fecal. Both are life threatening conditions requiring emergency surgery. The background in&#xD;
      terms of reasons for inflammation (diverticulitis) and perforation to develop is unknown. In&#xD;
      this study we focus on specific changes associated with inflammation, both in tissues and of&#xD;
      fecal and mucosal microbiota.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective study of abdominal fluid, periferal blood, tissues as well as feces in Patients&#xD;
      (perforated diverticulitis with peritonitis undergoing emergency surgery, Group I), and in&#xD;
      Controls (patients operated due to colorectal cancer, Group II; patients with mild&#xD;
      diverticulitis not needing surgery, Group III).&#xD;
&#xD;
      Immune acitvity in abdominal fluid and periferal blood by immunoassay of 92 individual&#xD;
      proteins. mRNA expression of 96 specific genes in tissue samples. Quatification of bacterial&#xD;
      diversity in feces and colon mucosa.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 21, 2021</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>inflammatory response</measure>
    <time_frame>index surgery (Groups I and II)/ emergency room (Group III)</time_frame>
    <description>determination of levels of 92 proteins in abdominal fluid and blood</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>inflammatory response in tissue</measure>
    <time_frame>index surgery (Groups I and II)/ emergency room (Group III)</time_frame>
    <description>RNA sequencing (96 spcific genes) in abdominal tissue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>microbiota composition</measure>
    <time_frame>index surgery (Groups I and II)/ emergency room (Group III)</time_frame>
    <description>PCR amplification, cloning and sequencing of genes</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Perforated Diverticulitis</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <description>Patients undergoing emergency surgery due to perforated diverticulitis with peritonitis.&#xD;
No intervention, samples from abdominal fluid, blood, tissue, feces</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <description>Patients with colorectal cancer undergoing elective surgery. No intervention. Samples as for Group I</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group III</arm_group_label>
    <description>Patients with mild diverticulitis, not undergoing surgery. No intervention. Samples from blood and feces.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      periferal blood, abdominal fluid, colon wall, feces&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The aim is to study immune responses in patients with perforated divrticulitis leading to&#xD;
        peritonitis and emergency surgery. This group will be compared with patients operated for&#xD;
        colorectal cancer and patients with uncomplicated (mild) diverticulitis not undergoing&#xD;
        surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signs of perforated diverticulitis with peritonitis and decision to perform emergency&#xD;
             surgery (Group I)&#xD;
&#xD;
          -  Signs of acute diverticulitis and no decision of emergency surgery (Group II)&#xD;
&#xD;
          -  Patients with colorectal cancer planned for elective surgery (Group III)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No surgery performed (Group I and III)&#xD;
&#xD;
          -  Withdrawn consent (any group)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eva Haglind, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sahlgrenska univesitetssjukhuset</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eva Haglind, MD, PhD</last_name>
    <phone>+46705349088</phone>
    <email>eva.haglind@vgregion.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anette Wedin</last_name>
    <phone>+46700651143</phone>
    <email>anette.wedin@vgregion.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital/Östra</name>
      <address>
        <city>Gothenburg</city>
        <state>Västra Götaland Region</state>
        <zip>SE 416 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eva Haglind, MD, PhD</last_name>
      <phone>+46705349088</phone>
      <email>eva.haglind@vgregion.se</email>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>December 23, 2022</last_update_submitted>
  <last_update_submitted_qc>December 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Eva Haglind, MD, PhD, professor</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>perforated diverticulitis</keyword>
  <keyword>peritonitis</keyword>
  <keyword>protein changes</keyword>
  <keyword>microbiota</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peritonitis</mesh_term>
    <mesh_term>Diverticulitis</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/NCT04427891
org study id: 2019-06114
nct id: NCT04427891
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Perforated diverticulitis of the colon can be complicated by peritonitis, either purulent or
      fecal. Both are life threatening conditions requiring emergency surgery. The background in
      terms of reasons for inflammation (diverticulitis) and perforation to develop is unknown. In
      this study we focus on specific changes associated with inflammation, both in tissues and of
      fecal and mucosal microbiota.
A prospective study of abdominal fluid, periferal blood, tissues as well as feces in Patients
      (perforated diverticulitis with peritonitis undergoing emergency surgery, Group I), and in
      Controls (patients operated due to colorectal cancer, Group II; patients with mild
      diverticulitis not needing surgery, Group III).

      Immune acitvity in abdominal fluid and periferal blood by immunoassay of 92 individual
      proteins. mRNA expression of 96 specific genes in tissue samples. Quatification of bacterial
      diversity in feces and colon mucosa.
observational model: Other
time perspective: Prospective
measure: inflammatory response
time frame: index surgery (Groups I and II)/ emergency room (Group III)
description: determination of levels of 92 proteins in abdominal fluid and blood
measure: inflammatory response in tissue
time frame: index surgery (Groups I and II)/ emergency room (Group III)
description: RNA sequencing (96 spcific genes) in abdominal tissue
measure: microbiota composition
time frame: index surgery (Groups I and II)/ emergency room (Group III)
description: PCR amplification, cloning and sequencing of genes
arm group label: Group I
description: Patients undergoing emergency surgery due to perforated diverticulitis with peritonitis.
No intervention, samples from abdominal fluid, blood, tissue, feces
arm group label: Group II
description: Patients with colorectal cancer undergoing elective surgery. No intervention. Samples as for Group I
arm group label: Group III
description: Patients with mild diverticulitis, not undergoing surgery. No intervention. Samples from blood and feces.
periferal blood, abdominal fluid, colon wall, feces
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Eva Haglind, MD,PhD
role: Principal Investigator
affiliation: Sahlgrenska univesitetssjukhuset
last name: Eva Haglind, MD, PhD
phone: +46705349088
email: eva.haglind@vgregion.se
last name: Anette Wedin
phone: +46700651143
email: anette.wedin@vgregion.se
facility: 
status: Recruiting
contact: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Eva Haglind, MD, PhD, professor
investigator title: professor
mesh term: Peritonitis
mesh term: Diverticulitis
sharing ipd: No