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

Not Applicable

• Conditions: Colon Carcinoma
• Interventions: Procedure: fluid administration

• Registration Number: NCT02991092
• Lead Sponsor: Quan Wang

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 Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-30
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-08
• Last Update Submitted: 2016-12-08
• Study First Posted: 2016-12-13
• Last Update Posted: 2016-12-13
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the experimental group	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
the control group	fluid administration	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

Name	Time	Method
recovery time of intestinal function	within the first 30 days (plus or minus 3 days) after surgery

Secondary Outcome Measures

Name	Time	Method
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
TNF-alpha	the first day to the forth day After the operation