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
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:
- 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.
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
|
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.
|
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
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
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.