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

Sponsor
Quan Wang (Other)
Overall Status
Unknown status
CT.gov ID
NCT02991092
Collaborator
(none)
150
2
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: fluid administration
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer After Laparoscopic Surgery.
Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
May 1, 2017
Anticipated Study Completion Date :
May 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. recovery time of intestinal function [within the first 30 days (plus or minus 3 days) after surgery]

Secondary Outcome Measures

  1. TNF-alpha [the first day to the forth day After the operation]

  2. CRP[=C reactive protein]ba [the first day to the forth day After the operation]

  3. IL-10[=interleukin-10] [the first day to the forth day After the operation]

  4. BNP[=type B natriuretic peptide] [the first day to the forth day After the operation]

  5. hospitalization time after operation(day) [within the first 30 days (plus or minus 3 days) after surgery]

Other Outcome Measures

  1. inferior vena cava diameter(mm) [Twenty-fourth hours after operation and before operation]

  2. stat body height(m) [Twenty-fourth hours after operation and before operation]

  3. body weight(Kg) [Twenty-fourth hours after operation and before operation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Quan Wang

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Quan Wang, Deputy chief physician, The First Hospital of Jilin University
ClinicalTrials.gov Identifier:
NCT02991092
Other Study ID Numbers:
  • FTSlapCC
First Posted:
Dec 13, 2016
Last Update Posted:
Dec 13, 2016
Last Verified:
Dec 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Quan Wang, Deputy chief physician, The First Hospital of Jilin University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 13, 2016