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

Colon Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02991092
• Other study ID #: FTSlapCC
• Status: Active, not recruiting
• Phase: N/A
• First received: November 30, 2016
• Last updated: December 8, 2016
• Start date: November 2016
• Est. completion date: May 2017

Study information

• Verified date: December 2016
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colon Carcinoma
• Colonic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Quan Wang

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	inferior vena cava diameter(mm)		Twenty-fourth hours after operation and before operation	Yes
Other	stat body height(m)		Twenty-fourth hours after operation and before operation	Yes
Other	body weight(Kg)		Twenty-fourth hours after operation and before operation	Yes
Primary	recovery time of intestinal function		within the first 30 days (plus or minus 3 days) after surgery	Yes
Secondary	TNF-alpha		the first day to the forth day After the operation	Yes
Secondary	CRP[=C reactive protein]ba		the first day to the forth day After the operation	Yes
Secondary	IL-10[=interleukin-10]		the first day to the forth day After the operation	Yes
Secondary	BNP[=type B natriuretic peptide]		the first day to the forth day After the operation	Yes
Secondary	hospitalization time after operation(day)		within the first 30 days (plus or minus 3 days) after surgery	Yes