NCT02991092

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

6 months

First QC Date

November 30, 2016

Last Update Submit

December 8, 2016

Conditions

Colon Carcinoma

Keywords

colon carcinomaliquid treatmentfast-track surgery

Outcome Measures

Primary Outcomes (1)

  • recovery time of intestinal function

    within the first 30 days (plus or minus 3 days) after surgery

Secondary Outcomes (5)

  • TNF-alpha

    the first day to the forth day After the operation

  • CRP[=C reactive protein]ba

    the 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 Outcomes (3)

  • inferior vena cava diameter（mm）

    Twenty-fourth hours after operation and before operation

  • stat body height（m）

    Twenty-fourth hours after operation and before operation

  • body weight（Kg）

    Twenty-fourth hours after operation and before operation

Study Arms (2)

the experimental group

EXPERIMENTAL

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

the control group

OTHER

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

Interventions

fluid administrationPROCEDURE

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 groupthe experimental group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the age of 18-70 years old
  • the pathological diagnosis of colon cancer patients
  • no surgical intervention.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Hypodermoclysis

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Infusions, SubcutaneousInfusions, ParenteralDrug Administration RoutesDrug TherapyTherapeuticsFluid Therapy

Study Officials

  • Shengk Qiu, master

    qiusk7009@sina.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy chief physician

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 13, 2016

Study Start

November 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

December 13, 2016

Record last verified: 2016-12