Clinical trial NCT02991092: The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer.（FTSlapCC)
Official title: The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer After Laparoscopic Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Carcinoma
Keywords: colon carcinoma
liquid treatment
fast-track surgery
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: recovery time of intestinal function
timeFrame: within the first 30 days (plus or minus 3 days) after surgery
Secondary outcomes:
measure: TNF-alpha
timeFrame: the first day to the forth day After the operation
measure: CRP[=C reactive protein]ba
timeFrame: the first day to the forth day After the operation
measure: IL-10[=interleukin-10]
timeFrame: the first day to the forth day After the operation
measure: BNP[=type B natriuretic peptide]
timeFrame: the first day to the forth day After the operation
measure: hospitalization time after operation（day）
timeFrame: within the first 30 days (plus or minus 3 days) after surgery
Other outcomes:
measure: inferior vena cava diameter（mm）
timeFrame: Twenty-fourth hours after operation and before operation
measure: stat body height（m）
timeFrame: Twenty-fourth hours after operation and before operation
measure: body weight（Kg）
timeFrame: Twenty-fourth hours after operation and before operation
Locations:
Study officials:
affiliation: qiusk7009@sina.com
name: Shengk Qiu, master
role: PRINCIPAL_INVESTIGATOR
References: