<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/NCT04442568</url>
  </required_header>
  <id_info>
    <org_study_id>ERAS-LSG</org_study_id>
    <nct_id>NCT04442568</nct_id>
  </id_info>
  <brief_title>Impact of ERAS in LSG</brief_title>
  <acronym>ERAS-LSG</acronym>
  <official_title>Enhanced Recovery After Surgery Protocol in Laparoscopic Sleeve Gastrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umraniye Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umraniye Education and Research Hospital</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>
      Patients with BMI &gt;35 and chronic diseases or BMI &gt;40 will be scheduled to receive&#xD;
      Laparoscopic Sleeve Gastrectomy (LSG). Two groups are planned according to receive Enhance&#xD;
      recovery after surgery (ERAS) protocol or not. All participants will receive standard LSG.&#xD;
      Participants of ERAS will receive anesthesia and post-surgical nutrition protocol which are&#xD;
      determined for ERAS. All patients will be checked for status of pain with VAS score, nausea&#xD;
      and vomiting with PONV score at postoperative 2nd hour, 12th hour. In ERAS group liquid oral&#xD;
      intake will be started between postoperative 2nd and 4th hours. In no ERAS group liquid oral&#xD;
      intake will be started in the morning of postoperative first day. The patients who provides&#xD;
      discharge criterias will be discahrged. these criterias are; To provide adequate pain relief&#xD;
      with paracetamol and nonsteroidal painkillers, No wound problem, No complications after&#xD;
      surgery, Pulse rate &lt;90 beats / min, temperature ≤ 37 · 5 ° C, respiratory rate, &lt;20 breaths&#xD;
      / minute, To be able to mobilize easily, To be able to drink 1 liter of water after surgery.&#xD;
&#xD;
      Emergency admissions of the participants within a month after surgery will be recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2021</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>
    <intervention_model_description>Patients</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>till discharge, an average of 36 hours</time_frame>
    <description>the time (in hours) from the start of surgery to the discharge of patients in both groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of emergency re-admission after surgery</measure>
    <time_frame>during postoperative first 30 days</time_frame>
    <description>number of emergency re-admission after surgery due to complications or patients discomfort</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Score of Visual analog scale</measure>
    <time_frame>postoperative 24 hours</time_frame>
    <description>VAS scores that evaluate postoperative pain in both groups will be compared (minimum score 0, maxımum score 10 and higher scores mean a worse outcome)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Laparoscopic Sleeve Gastrectomy</condition>
  <condition>Enhanced Recovery After Surgery</condition>
  <condition>Pain, Postoperative</condition>
  <condition>Nausea, Postoperative</condition>
  <condition>Vomiting, Postoperative</condition>
  <arm_group>
    <arm_group_label>ERAS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>all patients in this group will be performed LSG under a specified anesthesia protocol. This protocol includes non-opioid analgesia and sedation. Also short-acting anesthetic drugs will be used in this arm. The patients in this arm will be mobilized in the second hour postoperatively, also will be started oral intake between second and fourth hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no ERAS</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>all patients in this group will be performed LSG under a conventional anesthesia protocol which is depended on the anesthesiologist . This protocol includes opioid analgesia and sedation. Also short and long acting anesthetic drugs will be used in this arm. The patients in this arm will be mobilized in the fourth hour postoperatively, also will be started oral intake in the next day morning after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ERAS</intervention_name>
    <description>early mobilisation, early oral intake, early discharge</description>
    <arm_group_label>ERAS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  must be performed laparoscopic sleeve gastrectomy&#xD;
&#xD;
          -  body mass index &gt; 35 with a comorbidıty or ,body mass index &gt; 40&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  surgery with peroperative complication&#xD;
&#xD;
          -  revision surgery applications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Umraniye Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Abdullah Sisik</investigator_full_name>
    <investigator_title>Assoc. Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <!-- 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/NCT04442568
org study id: ERAS-LSG
nct id: NCT04442568
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients with BMI >35 and chronic diseases or BMI >40 will be scheduled to receive
      Laparoscopic Sleeve Gastrectomy (LSG). Two groups are planned according to receive Enhance
      recovery after surgery (ERAS) protocol or not. All participants will receive standard LSG.
      Participants of ERAS will receive anesthesia and post-surgical nutrition protocol which are
      determined for ERAS. All patients will be checked for status of pain with VAS score, nausea
      and vomiting with PONV score at postoperative 2nd hour, 12th hour. In ERAS group liquid oral
      intake will be started between postoperative 2nd and 4th hours. In no ERAS group liquid oral
      intake will be started in the morning of postoperative first day. The patients who provides
      discharge criterias will be discahrged. these criterias are; To provide adequate pain relief
      with paracetamol and nonsteroidal painkillers, No wound problem, No complications after
      surgery, Pulse rate <90 beats / min, temperature ≤ 37 · 5 ° C, respiratory rate, <20 breaths
      / minute, To be able to mobilize easily, To be able to drink 1 liter of water after surgery.

      Emergency admissions of the participants within a month after surgery will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients
primary purpose: Health Services Research
masking: None (Open Label)
measure: length of hospital stay
time frame: till discharge, an average of 36 hours
description: the time (in hours) from the start of surgery to the discharge of patients in both groups
measure: number of emergency re-admission after surgery
time frame: during postoperative first 30 days
description: number of emergency re-admission after surgery due to complications or patients discomfort
measure: Score of Visual analog scale
time frame: postoperative 24 hours
description: VAS scores that evaluate postoperative pain in both groups will be compared (minimum score 0, maxımum score 10 and higher scores mean a worse outcome)
arm group label: ERAS
arm group type: Active Comparator
description: all patients in this group will be performed LSG under a specified anesthesia protocol. This protocol includes non-opioid analgesia and sedation. Also short-acting anesthetic drugs will be used in this arm. The patients in this arm will be mobilized in the second hour postoperatively, also will be started oral intake between second and fourth hours.
arm group label: no ERAS
arm group type: No Intervention
description: all patients in this group will be performed LSG under a conventional anesthesia protocol which is depended on the anesthesiologist . This protocol includes opioid analgesia and sedation. Also short and long acting anesthetic drugs will be used in this arm. The patients in this arm will be mobilized in the fourth hour postoperatively, also will be started oral intake in the next day morning after surgery.
intervention type: Other
intervention name: ERAS
description: early mobilisation, early oral intake, early discharge
arm group label: ERAS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Umraniye Education and Research Hospital
investigator full name: Abdullah Sisik
investigator title: Assoc. Prof.
mesh term: Vomiting
mesh term: Pain, Postoperative
mesh term: Postoperative Nausea and Vomiting