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The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer.(FTSlapCC)

Primary Purpose

Colon Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fluid administration
Sponsored by
Quan Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colon Carcinoma focused on measuring colon carcinoma, liquid treatment, fast-track surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. the age of 18-70 years old
  2. the pathological diagnosis of colon cancer patients
  3. no surgical intervention.

Exclusion Criteria:

  1. patients with heart, lung, liver, renal function were significantly abnormal
  2. body mass index kg >35 / m2
  3. pregnancy
  4. sepsis or systemic inflammatory response syndrome patients.
  5. patients with severe malnutrition.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    the experimental group

    the control group

    Arm 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.

    Outcomes

    Primary Outcome Measures

    recovery time of intestinal function

    Secondary Outcome Measures

    TNF-alpha
    CRP[=C reactive protein]ba
    IL-10[=interleukin-10]
    BNP[=type B natriuretic peptide]
    hospitalization time after operation(day)

    Full Information

    First Posted
    November 30, 2016
    Last Updated
    December 8, 2016
    Sponsor
    Quan Wang
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02991092
    Brief Title
    The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer.(FTSlapCC)
    Official Title
    The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer After Laparoscopic Surgery.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    May 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Quan Wang

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To compare the influence of two different fluid administration strategies on the clinical efficacy of patients with colorectal carcinoma during the fast-track surgery.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colon Carcinoma
    Keywords
    colon carcinoma, liquid treatment, fast-track surgery

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    the experimental group
    Arm Type
    Experimental
    Arm 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 Title
    the control group
    Arm Type
    Other
    Arm 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(s)
    fluid administration
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    recovery time of intestinal function
    Time Frame
    within the first 30 days (plus or minus 3 days) after surgery
    Secondary Outcome Measure Information:
    Title
    TNF-alpha
    Time Frame
    the first day to the forth day After the operation
    Title
    CRP[=C reactive protein]ba
    Time Frame
    the first day to the forth day After the operation
    Title
    IL-10[=interleukin-10]
    Time Frame
    the first day to the forth day After the operation
    Title
    BNP[=type B natriuretic peptide]
    Time Frame
    the first day to the forth day After the operation
    Title
    hospitalization time after operation(day)
    Time Frame
    within the first 30 days (plus or minus 3 days) after surgery
    Other Pre-specified Outcome Measures:
    Title
    inferior vena cava diameter(mm)
    Time Frame
    Twenty-fourth hours after operation and before operation
    Title
    stat body height(m)
    Time Frame
    Twenty-fourth hours after operation and before operation
    Title
    body weight(Kg)
    Time Frame
    Twenty-fourth hours after operation and before operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: the age of 18-70 years old the pathological diagnosis of colon cancer patients no surgical intervention. Exclusion Criteria: patients with heart, lung, liver, renal function were significantly abnormal body mass index kg >35 / m2 pregnancy sepsis or systemic inflammatory response syndrome patients. patients with severe malnutrition.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shengk Qiu, master
    Organizational Affiliation
    qiusk7009@sina.com
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer.(FTSlapCC)

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