xml: <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/NCT06018961</url>
    </required_header>
    <id_info>
      <org_study_id>RC31/22/0491</org_study_id>
      <secondary_id>2022-A02834-39</secondary_id>
      <nct_id>NCT06018961</nct_id>
    </id_info>
    <brief_title>Study of Postoperative Ileus in Digestive Surgery</brief_title>
    <acronym>IPCID</acronym>
    <official_title>Study of Postoperative Ileus in Digestive Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Toulouse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital, Toulouse</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>
        Post-operative ileus is a temporary stoppage of bowel function following surgery. Indeed it&#xD;
        can occur in 20% of cases during post-operative follow-up of bowel surgery. The absence of&#xD;
        resumption of transit can lead to the implementation of specific treatments such as the&#xD;
        placement of a nasogastric tube and drug treatments. To date, the definition of this event is&#xD;
        not accepted by everyone and is not based on reproducible evaluation criteria. The main&#xD;
        objective of this study is to evaluate a score used to date to define postoperative ileus,&#xD;
        the IFEED score, and to compare it to the length of postoperative stay.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Postoperative ileus (also known as paralytic ileus) is defined as a temporary cessation of&#xD;
        gastrointestinal peristalsis. This complication occurs mainly following gastrointestinal&#xD;
        surgery. It can be noted that postoperative ileus also occurs postoperatively after pelvic&#xD;
        and extra-abdominal surgery with a lower incidence. The incidence of ileus varies depending&#xD;
        on the cohorts, however the rate of occurrence can be up to 20% post-operative colorectal&#xD;
        surgery.The main principles of treatment are the fasting of the patient and the introduction&#xD;
        of a nasogastric tube to ensure gastric emptying in order to prevent complications of&#xD;
        vomiting such as bronchial aspiration. This pathological phenomenon is frequent and&#xD;
        significantly lengthens the duration of hospitalization and postoperative morbidity and&#xD;
        mortality. The duration of hospitalization is the only objective and reproducible criterion&#xD;
        in the evaluation of ileus. One of the problems of postoperative ileus is first of all its&#xD;
        evaluation and the implementation of a reproducible definition. A recent consensus conference&#xD;
        of the American Society for Engaged Recovery and Perioperative Quality Initiative proposed a&#xD;
        return definition of transit based on an IFEED (Intake-Feeling Nauseated-Emesis-Physical&#xD;
        Exam-Duration of Symptoms) clinical score. However, this score has never been evaluated&#xD;
        prospectively in a cohort of patients operated on for pathologies of the digestive tract.&#xD;
        This is a descriptive, diagnostic, prospective, monocentric study. We will include patients&#xD;
        entering our care sector for a gastrointestinal surgery. We will follow patient from the&#xD;
        surgery to the end of their hospital stay.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 15, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 15, 2025</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Complications of post-operative ileus surgery</measure>
      <time_frame>1 month</time_frame>
      <description>Correlation between length of stay and Intake-Feeling nauseated-Emesis-physical Exam-Duration of symptoms (IFEED) score.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">161</enrollment>
    <condition>Colorectal Surgery</condition>
    <arm_group>
      <arm_group_label>Adult patients with digestive surgery</arm_group_label>
      <description>Patients who have planned abdominal surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Post-operative ileus surgery</intervention_name>
      <description>Collection of ileus events, items of IFEED score and surgical complications</description>
      <arm_group_label>Adult patients with digestive surgery</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Population who have planned abdominal surgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient entering our care sector for surgical management of a pathology affecting the&#xD;
               digestive tract:&#xD;
  &#xD;
            -  Colorectal cancer&#xD;
  &#xD;
            -  Chronic inflammatory bowel disease&#xD;
  &#xD;
            -  Colonic diverticulosis.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient treated for digestive resection with associated resection procedure or to be&#xD;
               treated with intraperitoneal chemotherapy.&#xD;
  &#xD;
            -  Patient presenting during hospitalization with an ileus secondary to another&#xD;
               intra-abdominal complication.&#xD;
  &#xD;
            -  Patient cared for in an emergency&#xD;
  &#xD;
            -  Hepatic resection or other associated metastatic site&#xD;
  &#xD;
            -  Multiple digestive resection&#xD;
  &#xD;
            -  Colorectal anastomosis less than 7 cm from the anal margin (below the Pouch of&#xD;
               Douglas)&#xD;
  &#xD;
            -  Patient with American Society of Anesthesiologists physical status (ASA) score &gt; 2&#xD;
  &#xD;
            -  Patient with an Eastern Cooperative Oncology Group (ECOG) Performance Status Scale &gt;2&#xD;
  &#xD;
            -  Pregnant or breastfeeding women&#xD;
  &#xD;
            -  Patient under a protection regime for adults (guardianship, curators, safeguard of&#xD;
               justice)&#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>Guillaume LE COSQUER, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Toulouse</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Guillaume LE COSQUER, MD</last_name>
      <phone>5 61 32 27 61</phone>
      <phone_ext>+33</phone_ext>
      <email>lecosquer.g@chu-toulouse.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Guillaume LE COSQUER</name>
        <address>
          <city>Toulouse</city>
          <zip>31000</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Guillaume LE COSQUER, MD</last_name>
        <phone>561322761</phone>
        <phone_ext>+33</phone_ext>
        <email>lecosquer.g@chu-toulouse.fr</email>
      </contact>
      <investigator>
        <last_name>Guillaume LE COSQUER, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Ileus</keyword>
    <keyword>Colorectal surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ileus</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06018961
  org study id: RC31/22/0491
  secondary id: 2022-A02834-39
  nct id: NCT06018961
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Post-operative ileus is a temporary stoppage of bowel function following surgery. Indeed it
        can occur in 20% of cases during post-operative follow-up of bowel surgery. The absence of
        resumption of transit can lead to the implementation of specific treatments such as the
        placement of a nasogastric tube and drug treatments. To date, the definition of this event is
        not accepted by everyone and is not based on reproducible evaluation criteria. The main
        objective of this study is to evaluate a score used to date to define postoperative ileus,
        the IFEED score, and to compare it to the length of postoperative stay.
  Postoperative ileus (also known as paralytic ileus) is defined as a temporary cessation of
        gastrointestinal peristalsis. This complication occurs mainly following gastrointestinal
        surgery. It can be noted that postoperative ileus also occurs postoperatively after pelvic
        and extra-abdominal surgery with a lower incidence. The incidence of ileus varies depending
        on the cohorts, however the rate of occurrence can be up to 20% post-operative colorectal
        surgery.The main principles of treatment are the fasting of the patient and the introduction
        of a nasogastric tube to ensure gastric emptying in order to prevent complications of
        vomiting such as bronchial aspiration. This pathological phenomenon is frequent and
        significantly lengthens the duration of hospitalization and postoperative morbidity and
        mortality. The duration of hospitalization is the only objective and reproducible criterion
        in the evaluation of ileus. One of the problems of postoperative ileus is first of all its
        evaluation and the implementation of a reproducible definition. A recent consensus conference
        of the American Society for Engaged Recovery and Perioperative Quality Initiative proposed a
        return definition of transit based on an IFEED (Intake-Feeling Nauseated-Emesis-Physical
        Exam-Duration of Symptoms) clinical score. However, this score has never been evaluated
        prospectively in a cohort of patients operated on for pathologies of the digestive tract.
        This is a descriptive, diagnostic, prospective, monocentric study. We will include patients
        entering our care sector for a gastrointestinal surgery. We will follow patient from the
        surgery to the end of their hospital stay.
  observational model: Case-Only
  time perspective: Prospective
  measure: Complications of post-operative ileus surgery
  time frame: 1 month
  description: Correlation between length of stay and Intake-Feeling nauseated-Emesis-physical Exam-Duration of symptoms (IFEED) score.
  arm group label: Adult patients with digestive surgery
  description: Patients who have planned abdominal surgery
  intervention type: Other
  intervention name: Post-operative ileus surgery
  description: Collection of ileus events, items of IFEED score and surgical complications
  arm group label: Adult patients with digestive surgery
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Guillaume LE COSQUER, MD
  role: Principal Investigator
  affiliation: University Hospital, Toulouse
  last name: Guillaume LE COSQUER, MD
  phone: 5 61 32 27 61
  phone ext: +33
  email: lecosquer.g@chu-toulouse.fr
  facility: 
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Ileus