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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer After Laparoscopic Surgery.

Conditions
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Colon Carcinoma

Intervention / Treatment
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* Procedure: fluid administration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the experimental group<br>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<br>* 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.<br>|
| Other: the control group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery time of intestinal function |  | within the first 30 days (plus or minus 3 days) after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNF-alpha |  | the first day to the forth day After the operation | 
| CRP[=C reactive protein]ba |  | the first day to the forth day After the operation | 
| IL-10[=interleukin-10] |  | the first day to the forth day After the operation | 
| BNP[=type B natriuretic peptide] |  | the first day to the forth day After the operation | 
| hospitalization time after operation（day） |  | within the first 30 days (plus or minus 3 days) after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon carcinoma, liquid treatment, fast-track surgery