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Trial record 11 of 1690 for:    colon cancer AND Intestinal Neoplasms

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

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ClinicalTrials.gov Identifier: NCT02991092
Recruitment Status : Unknown
Verified December 2016 by Quan Wang, First Hospital of Jilin University.
Recruitment status was:  Active, not recruiting
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Quan Wang, First Hospital of Jilin University

Tracking Information
First Submitted Date  ICMJE November 30, 2016
First Posted Date  ICMJE December 13, 2016
Last Update Posted Date December 13, 2016
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
recovery time of intestinal function [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
  • TNF-alpha [ Time Frame: the first day to the forth day After the operation ]
  • CRP[=C reactive protein]ba [ Time Frame: the first day to the forth day After the operation ]
  • IL-10[=interleukin-10] [ Time Frame: the first day to the forth day After the operation ]
  • BNP[=type B natriuretic peptide] [ Time Frame: the first day to the forth day After the operation ]
  • hospitalization time after operation(day) [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 8, 2016)
  • inferior vena cava diameter(mm) [ Time Frame: Twenty-fourth hours after operation and before operation ]
  • stat body height(m) [ Time Frame: Twenty-fourth hours after operation and before operation ]
  • body weight(Kg) [ Time Frame: Twenty-fourth hours after operation and before operation ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer.(FTSlapCC)
Official Title  ICMJE The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer After Laparoscopic Surgery.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Colon Carcinoma
Intervention  ICMJE Procedure: fluid administration
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.
Study Arms  ICMJE
  • Experimental: the experimental group
    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
    Intervention: Procedure: fluid administration
  • the control group
    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: Procedure: fluid administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: December 8, 2016)
150
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2017
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02991092
Other Study ID Numbers  ICMJE FTSlapCC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Quan Wang, First Hospital of Jilin University
Study Sponsor  ICMJE Quan Wang
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shengk Qiu, master qiusk7009@sina.com
PRS Account First Hospital of Jilin University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP