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

December 8, 2016 updated by: Quan Wang

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

To compare the influence of two different fluid administration strategies on the clinical efficacy of patients with colorectal carcinoma during the fast-track surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
TNF-alpha
Time Frame: the first day to the forth day After the operation
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
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
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
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
within the first 30 days (plus or minus 3 days) after surgery

Other Outcome Measures

Outcome Measure
Time Frame
inferior vena cava diameter（mm）
Time Frame: Twenty-fourth hours after operation and before operation
Twenty-fourth hours after operation and before operation
stat body height（m）
Time Frame: Twenty-fourth hours after operation and before operation
Twenty-fourth hours after operation and before operation
body weight（Kg）
Time Frame: Twenty-fourth hours after operation and before operation
Twenty-fourth hours after operation and before operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quan Wang

Investigators

  • Principal Investigator: Shengk Qiu, master, qiusk7009@sina.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

May 1, 2017

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (ESTIMATE)

December 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FTSlapCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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