<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/NCT03231423</url>
  </required_header>
  <id_info>
    <org_study_id>2016/181</org_study_id>
    <nct_id>NCT03231423</nct_id>
  </id_info>
  <brief_title>Effect of Drainage on Laparoscopic Gastric Bypass Surgery</brief_title>
  <official_title>Effect of Drain Usage on Patient Comfort on Laparoscopic Gastric Bypass Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inonu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inonu University</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>
      Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with&#xD;
      improvements in minimally invasive surgery. Ensuring patient comfort and early return to life&#xD;
      are the criteria that should be given priority in this treatment method. The purpose of this&#xD;
      study is to determine the use of drain, which closely affects these criteria; And the effect&#xD;
      on patient comfort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Question the necessity of routine use of drain in RYGB surgeon&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 9, 2016</start_date>
  <completion_date type="Actual">June 22, 2017</completion_date>
  <primary_completion_date type="Actual">June 22, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3-Item Pain Intensity measyre (P3)</measure>
    <time_frame>8 months</time_frame>
    <description>self reported pain intensity morning, second day and third day. Each item is scored 0-10 ( 0: no pain- 10: pain as bad as can be)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Obesity, Morbid</condition>
  <arm_group>
    <arm_group_label>DRAIN PLACEMENT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Effects of drainage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DRAIN NOT PLACED</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Effects of not using drain</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Drainage</intervention_name>
    <description>Using drain after operation</description>
    <arm_group_label>DRAIN PLACEMENT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Morbid obese patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries&#xD;
             during LRYGBP and those who had previously undergone obesity surgery (revision&#xD;
             surgery) were excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inonu University</investigator_affiliation>
    <investigator_full_name>Ersin Gündoğan</investigator_full_name>
    <investigator_title>Operator doctor</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>VAS</keyword>
  <keyword>Pain</keyword>
  <keyword>Laparoscopy</keyword>
  <keyword>Bypass</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</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/NCT03231423
org study id: 2016/181
nct id: NCT03231423
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with
      improvements in minimally invasive surgery. Ensuring patient comfort and early return to life
      are the criteria that should be given priority in this treatment method. The purpose of this
      study is to determine the use of drain, which closely affects these criteria; And the effect
      on patient comfort.
Question the necessity of routine use of drain in RYGB surgeon
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 3-Item Pain Intensity measyre (P3)
time frame: 8 months
description: self reported pain intensity morning, second day and third day. Each item is scored 0-10 ( 0: no pain- 10: pain as bad as can be)
arm group label: DRAIN PLACEMENT
arm group type: Experimental
description: Effects of drainage
arm group label: DRAIN NOT PLACED
arm group type: No Intervention
description: Effects of not using drain
intervention type: Other
intervention name: Drainage
description: Using drain after operation
arm group label: DRAIN PLACEMENT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Inonu University
investigator full name: Ersin Gündoğan
investigator title: Operator doctor
mesh term: Obesity, Morbid
sharing ipd: No