<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/NCT02991092</url>
  </required_header>
  <id_info>
    <org_study_id>FTSlapCC</org_study_id>
    <nct_id>NCT02991092</nct_id>
  </id_info>
  <brief_title>The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer.（FTSlapCC)</brief_title>
  <official_title>The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer After Laparoscopic Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Quan Wang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Hospital of Jilin University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the influence of two different fluid administration strategies on the clinical&#xD;
      efficacy of patients with colorectal carcinoma during the fast-track surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients that were diagnosed with colorectal carcinoma by the First Hospital of Jilin&#xD;
      University and were scheduled to undergo the laparoscopic surgery were prospectively included&#xD;
      and divided into the experimental group and the control group with the random number method.&#xD;
      After surgery, patients in the experiment group were provided with intravenous fluid&#xD;
      administration at 1.0ml/Kg/h and encouraged to take food and drink water early after surgery,&#xD;
      and the intravenous fluid administration was stopped immediately when the oral intake was&#xD;
      more than 1500ml/h; patients in the control group strictly followed the fasting and were&#xD;
      provided with the intravenous fluid administration according to &quot;Total amount of fluid =&#xD;
      physiological requirement + additional loss (fever + gastrointestinal decompression) + amount&#xD;
      lost&quot; until their intestinal function completely recovered. The blood volume change&#xD;
      indicators (heart rate, mean arterial pressure, oxyhemoglobin saturation, inferior vena cava&#xD;
      diameter /body surface area (VCD), intra-abdominal pressure, specific gravity of urine, BNP,&#xD;
      etc.) and inflammation indicators (CRP, IL-6, TNF-a) of the two groups of patients were&#xD;
      observed and a comparison was made of the recovery time of intestinal function, incidence of&#xD;
      complications, hospitalization time after operation and hospitalization expenses of the two&#xD;
      groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">May 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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>recovery time of intestinal function</measure>
    <time_frame>within the first 30 days (plus or minus 3 days) after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>TNF-alpha</measure>
    <time_frame>the first day to the forth day After the operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP[=C reactive protein]ba</measure>
    <time_frame>the first day to the forth day After the operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-10[=interleukin-10]</measure>
    <time_frame>the first day to the forth day After the operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BNP[=type B natriuretic peptide]</measure>
    <time_frame>the first day to the forth day After the operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospitalization time after operation（day）</measure>
    <time_frame>within the first 30 days (plus or minus 3 days) after surgery</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>inferior vena cava diameter（mm）</measure>
    <time_frame>Twenty-fourth hours after operation and before operation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>stat body height（m）</measure>
    <time_frame>Twenty-fourth hours after operation and before operation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>body weight（Kg）</measure>
    <time_frame>Twenty-fourth hours after operation and before operation</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Colon Carcinoma</condition>
  <arm_group>
    <arm_group_label>the experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After surgery, patients in the experiment group were provided with intravenous fluid administration at 1.0ml/Kg/h and encouraged to take food and drink water early after surgery, and the intravenous fluid administration was stopped immediately when the oral intake was more than 1500ml/h</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients in the control group strictly followed the fasting and were provided with the intravenous fluid administration according to &quot;Total amount of fluid = physiological requirement + additional loss (fever + gastrointestinal decompression) + amount lost&quot; until their intestinal function completely recovered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>fluid administration</intervention_name>
    <description>After surgery, patients in the experiment group were provided with intravenous fluid administration at 1.0ml/Kg/h and encouraged to take food and drink water early after surgery, and the intravenous fluid administration was stopped immediately when the oral intake was more than 1500ml/h; patients in the control group strictly followed the fasting and were provided with the intravenous fluid administration according to &quot;Total amount of fluid = physiological requirement + additional loss (fever + gastrointestinal decompression) + amount lost&quot; until their intestinal function completely recovered.</description>
    <arm_group_label>the control group</arm_group_label>
    <arm_group_label>the experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. the age of 18-70 years old&#xD;
&#xD;
          2. the pathological diagnosis of colon cancer patients&#xD;
&#xD;
          3. no surgical intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients with heart, lung, liver, renal function were significantly abnormal&#xD;
&#xD;
          2. body mass index kg &gt;35 / m2&#xD;
&#xD;
          3. pregnancy&#xD;
&#xD;
          4. sepsis or systemic inflammatory response syndrome patients.&#xD;
&#xD;
          5. patients with severe malnutrition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shengk Qiu, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>qiusk7009@sina.com</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The First Hospital of Jilin University</investigator_affiliation>
    <investigator_full_name>Quan Wang</investigator_full_name>
    <investigator_title>Deputy chief physician</investigator_title>
  </responsible_party>
  <keyword>colon carcinoma</keyword>
  <keyword>liquid treatment</keyword>
  <keyword>fast-track surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 20, 2020</submitted>
    <returned>March 4, 2020</returned>
  </pending_results>
  <!-- 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/NCT02991092
org study id: FTSlapCC
nct id: NCT02991092
lead sponsor: 
has dmc: Yes
To compare the influence of two different fluid administration strategies on the clinical
      efficacy of patients with colorectal carcinoma during the fast-track surgery.
Patients that were diagnosed with colorectal carcinoma by the First Hospital of Jilin
      University and were scheduled to undergo the laparoscopic surgery were prospectively included
      and divided into the experimental group and the control group with the random number method.
      After surgery, patients in the experiment group were provided with intravenous fluid
      administration at 1.0ml/Kg/h and encouraged to take food and drink water early after surgery,
      and the intravenous fluid administration was stopped immediately when the oral intake was
      more than 1500ml/h; patients in the control group strictly followed the fasting and were
      provided with the intravenous fluid administration according to "Total amount of fluid =
      physiological requirement + additional loss (fever + gastrointestinal decompression) + amount
      lost" until their intestinal function completely recovered. The blood volume change
      indicators (heart rate, mean arterial pressure, oxyhemoglobin saturation, inferior vena cava
      diameter /body surface area (VCD), intra-abdominal pressure, specific gravity of urine, BNP,
      etc.) and inflammation indicators (CRP, IL-6, TNF-a) of the two groups of patients were
      observed and a comparison was made of the recovery time of intestinal function, incidence of
      complications, hospitalization time after operation and hospitalization expenses of the two
      groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: recovery time of intestinal function
time frame: within the first 30 days (plus or minus 3 days) after surgery
measure: TNF-alpha
time frame: the first day to the forth day After the operation
measure: CRP[=C reactive protein]ba
time frame: the first day to the forth day After the operation
measure: IL-10[=interleukin-10]
time frame: the first day to the forth day After the operation
measure: BNP[=type B natriuretic peptide]
time frame: the first day to the forth day After the operation
measure: hospitalization time after operation（day）
time frame: within the first 30 days (plus or minus 3 days) after surgery
measure: inferior vena cava diameter（mm）
time frame: Twenty-fourth hours after operation and before operation
measure: stat body height（m）
time frame: Twenty-fourth hours after operation and before operation
measure: body weight（Kg）
time frame: Twenty-fourth hours after operation and before operation
arm group label: the experimental group
arm group type: Experimental
description: After surgery, patients in the experiment group were provided with intravenous fluid administration at 1.0ml/Kg/h and encouraged to take food and drink water early after surgery, and the intravenous fluid administration was stopped immediately when the oral intake was more than 1500ml/h
arm group label: the control group
arm group type: Other
description: patients in the control group strictly followed the fasting and were provided with the intravenous fluid administration according to "Total amount of fluid = physiological requirement + additional loss (fever + gastrointestinal decompression) + amount lost" until their intestinal function completely recovered.
intervention type: Procedure
intervention name: fluid administration
description: After surgery, patients in the experiment group were provided with intravenous fluid administration at 1.0ml/Kg/h and encouraged to take food and drink water early after surgery, and the intravenous fluid administration was stopped immediately when the oral intake was more than 1500ml/h; patients in the control group strictly followed the fasting and were provided with the intravenous fluid administration according to "Total amount of fluid = physiological requirement + additional loss (fever + gastrointestinal decompression) + amount lost" until their intestinal function completely recovered.
arm group label: the control group
arm group label: the experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Shengk Qiu, master
role: Principal Investigator
affiliation: qiusk7009@sina.com
responsible party type: Sponsor-Investigator
investigator affiliation: The First Hospital of Jilin University
investigator full name: Quan Wang
investigator title: Deputy chief physician
mesh term: Colonic Neoplasms
sharing ipd: Undecided
submitted: February 20, 2020
returned: March 4, 2020