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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

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.

Condition or disease Intervention/treatment Phase
Colon Carcinoma Procedure: fluid administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer After Laparoscopic Surgery.
Study Start Date : November 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Arm Intervention/treatment
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
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.

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.
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.




Primary Outcome Measures :
  1. recovery time of intestinal function [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ]

Secondary Outcome Measures :
  1. TNF-alpha [ Time Frame: the first day to the forth day After the operation ]
  2. CRP[=C reactive protein]ba [ Time Frame: the first day to the forth day After the operation ]
  3. IL-10[=interleukin-10] [ Time Frame: the first day to the forth day After the operation ]
  4. BNP[=type B natriuretic peptide] [ Time Frame: the first day to the forth day After the operation ]
  5. hospitalization time after operation(day) [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ]

Other Outcome Measures:
  1. inferior vena cava diameter(mm) [ Time Frame: Twenty-fourth hours after operation and before operation ]
  2. stat body height(m) [ Time Frame: Twenty-fourth hours after operation and before operation ]
  3. body weight(Kg) [ Time Frame: Twenty-fourth hours after operation and before operation ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991092


Sponsors and Collaborators
Quan Wang
Investigators
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Principal Investigator: Shengk Qiu, master qiusk7009@sina.com

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Responsible Party: Quan Wang, Deputy chief physician, First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT02991092     History of Changes
Other Study ID Numbers: FTSlapCC
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Quan Wang, First Hospital of Jilin University:
colon carcinoma
liquid treatment
fast-track surgery

Additional relevant MeSH terms:
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Colonic Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases