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

NCT ID: NCT02991092

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Colon Carcinoma

Keywords

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colon carcinoma liquid treatment fast-track surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

fluid administration

Intervention Type PROCEDURE

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 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.

Group Type OTHER

fluid administration

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Quan Wang

OTHER

Sponsor Role lead

Responsible Party

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Quan Wang

Deputy chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shengk Qiu, master

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Other Identifiers

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FTSlapCC

Identifier Type: -

Identifier Source: org_study_id