<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/NCT03826251</url>
  </required_header>
  <id_info>
    <org_study_id>UH Angers 2018/75</org_study_id>
    <nct_id>NCT03826251</nct_id>
  </id_info>
  <brief_title>Small Bowel Obstruction and Surgery</brief_title>
  <official_title>Nasogastric Tube After Small Bowel Obstruction Surgery is Not Mandatory: a Retrospective Cohort Study</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>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>
      Postoperative management after small bowel obstruction (SBO) surgery is not consensual and&#xD;
      better knowledge of risk factors for postoperative morbidity could help to add evidence of&#xD;
      the feasibility of enhanced recovery programs (ERPs).&#xD;
&#xD;
      In elective surgery, ERPs have shown a significant benefit for the patient but this is not&#xD;
      performed routinely in emergency surgery due to the difficulty to avoid postoperative&#xD;
      nasogastric tube.&#xD;
&#xD;
      The aim was to identify risk factors for postoperative morbidity and for nasogastric tube&#xD;
      (NGT) replacement after SBO surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">June 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative morbidity</measure>
    <time_frame>within 30 days</time_frame>
    <description>morbidity classified according to Dindo Clavien classification</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nasogastric tube replacement</measure>
    <time_frame>within 30 days</time_frame>
    <description>nasogastric tube replacement after removal</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment>190</enrollment>
  <condition>Acute Small Intestine Obstruction</condition>
  <arm_group>
    <arm_group_label>systematic nasogastric tube</arm_group_label>
    <description>NGT was left systematically after surgery and removed after the first flattus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non systematic nasogastric tube</arm_group_label>
    <description>Nasogastric tube was removed immediately after surgery and was replaced in case of vomiting</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Nasogastric tube removal</intervention_name>
    <description>Nasogastric tube was removed immediately after surgery</description>
    <arm_group_label>Non systematic nasogastric tube</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing surgery for adhesive small bowel obstruction in the CHU of Angers&#xD;
        between January 1, 2014 and December 31, 2017&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Surgical management of Small bowel obstruction due to adhesions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  obstruction not caused by single band adhesion&#xD;
&#xD;
          -  matted adhesions, or if they were less than 18 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Obstruction</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/NCT03826251
org study id: UH Angers 2018/75
nct id: NCT03826251
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Postoperative management after small bowel obstruction (SBO) surgery is not consensual and
      better knowledge of risk factors for postoperative morbidity could help to add evidence of
      the feasibility of enhanced recovery programs (ERPs).

      In elective surgery, ERPs have shown a significant benefit for the patient but this is not
      performed routinely in emergency surgery due to the difficulty to avoid postoperative
      nasogastric tube.

      The aim was to identify risk factors for postoperative morbidity and for nasogastric tube
      (NGT) replacement after SBO surgery.
observational model: Cohort
time perspective: Retrospective
measure: postoperative morbidity
time frame: within 30 days
description: morbidity classified according to Dindo Clavien classification
measure: Nasogastric tube replacement
time frame: within 30 days
description: nasogastric tube replacement after removal
arm group label: systematic nasogastric tube
description: NGT was left systematically after surgery and removed after the first flattus
arm group label: Non systematic nasogastric tube
description: Nasogastric tube was removed immediately after surgery and was replaced in case of vomiting
intervention type: Procedure
intervention name: Nasogastric tube removal
description: Nasogastric tube was removed immediately after surgery
arm group label: Non systematic nasogastric tube
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Intestinal Obstruction
sharing ipd: No