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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02991092
Enrollment
150
Registered
2016-12-13
Start date
2016-11-30
Completion date
2017-05-31
Last updated
2016-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Carcinoma

Keywords

colon carcinoma, liquid treatment, fast-track surgery

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.

Interventions

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.

Sponsors

Quan Wang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frame
recovery time of intestinal functionwithin the first 30 days (plus or minus 3 days) after surgery

Secondary

MeasureTime frame
TNF-alphathe first day to the forth day After the operation
CRP[=C reactive protein]bathe 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

Other

MeasureTime frame
body weight(Kg)Twenty-fourth hours after operation and before operation
stat body height(m)Twenty-fourth hours after operation and before operation
inferior vena cava diameter(mm)Twenty-fourth hours after operation and before operation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026