<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/NCT04461067</url>
  </required_header>
  <id_info>
    <org_study_id>19.12.02.56807</org_study_id>
    <nct_id>NCT04461067</nct_id>
  </id_info>
  <brief_title>Gastric Volume and Colorectal Surgery</brief_title>
  <acronym>EVOL</acronym>
  <official_title>Ultrasonographic Evaluation of the Evolution of the Gastric Volume After Colorectal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</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>
      Postoperative ileus (POI) is a serious complication after colorectal surgery. One of its most&#xD;
      frequent consequences is the replacement of nasogastric tube because of the vomiting.&#xD;
      Vomiting is due to the distension of the stomach and information on the evolution of gastric&#xD;
      filling after surgery could help to better understand the physiopathology of POI. It could&#xD;
      also give indication to help the physician in the management of POI.&#xD;
&#xD;
      The ultrasonography has been shown to be a reliable technic to assess the gastric emptying.&#xD;
&#xD;
      To date, there is no indication in the literature about the evolution of the gastric filling&#xD;
      after colorectal surgery while these information could help to identify patients at risk for&#xD;
      POI and to predict the need for POI replacement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 8, 2020</start_date>
  <completion_date type="Anticipated">September 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diameter of the gastric antrum</measure>
    <time_frame>immediately before the procedure and each postoperative day up to discharge (mean 7 days)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative ileus</measure>
    <time_frame>in the morning up to 30 postoperative days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative quality of life: GIQLI</measure>
    <time_frame>before discharge</time_frame>
    <description>GIQLI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative morbidity</measure>
    <time_frame>within 30 postoperative days</time_frame>
    <description>Dindo Clavien Scale (from 1 (minor) to 5 (death))</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Postoperative Ileus</condition>
  <arm_group>
    <arm_group_label>Gastric antrum measurement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ultrasonography</intervention_name>
    <description>Ultrasonography of the stomach is performed to measure the diameter of the antrum</description>
    <arm_group_label>Gastric antrum measurement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient undergoing colorectal resection whatever the surgical access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contra-indication to ultrasonography performance&#xD;
&#xD;
          -  history of gastrectomy&#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>Aurélien VENARA, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Angers</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>aurélien venara, MD, PhD</last_name>
    <phone>0033241353618</phone>
    <email>auvenara@chu-angers.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aurélien VENARA</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 27, 2022</last_update_submitted>
  <last_update_submitted_qc>July 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04461067
org study id: 19.12.02.56807
nct id: NCT04461067
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Postoperative ileus (POI) is a serious complication after colorectal surgery. One of its most
      frequent consequences is the replacement of nasogastric tube because of the vomiting.
      Vomiting is due to the distension of the stomach and information on the evolution of gastric
      filling after surgery could help to better understand the physiopathology of POI. It could
      also give indication to help the physician in the management of POI.

      The ultrasonography has been shown to be a reliable technic to assess the gastric emptying.

      To date, there is no indication in the literature about the evolution of the gastric filling
      after colorectal surgery while these information could help to identify patients at risk for
      POI and to predict the need for POI replacement.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diameter of the gastric antrum
time frame: immediately before the procedure and each postoperative day up to discharge (mean 7 days)
measure: postoperative ileus
time frame: in the morning up to 30 postoperative days
measure: Postoperative quality of life: GIQLI
time frame: before discharge
description: GIQLI
measure: postoperative morbidity
time frame: within 30 postoperative days
description: Dindo Clavien Scale (from 1 (minor) to 5 (death))
arm group label: Gastric antrum measurement
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: ultrasonography
description: Ultrasonography of the stomach is performed to measure the diameter of the antrum
arm group label: Gastric antrum measurement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aurélien VENARA, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Angers
last name: aurélien venara, MD, PhD
phone: 0033241353618
email: auvenara@chu-angers.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
sharing ipd: No