Goal Directed Fluid Therapy and Postoperative Ileus

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

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-08-31

Brief Summary

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Despite Goal Directed Fluid Therapy (GDFT) has shown a reduction of hospitalization and overall complications in patients undergoing abdominal surgery, there is a need to address the effect of implementing GDFT on the incidence of specific surgical complications and in a context of en enhanced recovery program (ERP). Specifically, studies investigating the impact of GDFT on primary postoperative ileus (POI) in patients undergoing laparoscopic colorectal surgery and using an ERP are missing.

It is hypothesized that the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving Standard Fluid Therapy (SFT) after elective laparoscopic colorectal surgeries with an ERP program.

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Detailed Description

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Randomized Controlled Trial. Study population: elective laparoscopic colorectal resections with an Enhanced Recovery Program (ERP) Sample size: 128 patients (140 accounting for drops out)

Two arms:

GDFT: patients will receive GDFT esophageal doppler guided; SFT: patients will receive SFT based on standard anesthesia formula and international guidelines to calculate fluid requirements.

Study Hypothesis: the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving SFT after elective laparoscopic colorectal surgeries with an ERP program.

ERP: all patients will receive the same perioperative care according to the Enhanced Recovery After Surgery ERAS® program guidelines. Intravenous fluid will be stopped the first day after surgery. Patients will be allowed to have clear fluids the same day of surgery and diet, as tolerated, the first day after surgery.

Conditions

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Postoperative Ileus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Goal Directed Fluid Therapy (GDFT)

During surgery, patients in the Goal Directed Fluid Therapy (GDFT) will receive:

1. maintenance infusion of intravenous infusion of ringer lactate at a rate of 1.5 ml/Kg/hr to compensate insensible blood loss and fluid shift during surgery as recommended by perioperative fluid management guidelines for patients undergoing surgery with an enhanced recovery program and receiving a GDFT approach;
2. intraoperative intravenous boluses of colloids (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride-Voluven) guided by an algorithm based on Esophageal Doppler (ED) estimation of the stroke volume (SV) provided by the manufacture, and also used in other clinical trials.

Group Type EXPERIMENTAL

Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided

Intervention Type PROCEDURE

Standard Fluid Therapy

During surgery, patients will receive a maintenance infusion of intravenous infusion of ringer lactate as recommended by international guidelines and anesthesia text-books (Standard Fluid Therapy). In the Standard Fluid Therapy arm, the Esophageal Doppler (ED) monitor will be turned away from the anesthesia care provider, and the screen will be covered with an opaque card. The ED variables will be collected by an independent research personnel. Hemodynamic variables triggering extra fluid administration (Ringer Lactate or Voluven) will be decided based on the clinical judgment of the anesthetist in charge and will include: urinary output less than 0.5/ml/kg/hr, an increase in heart rate more than 20% above baseline or more than 110 beats/min, a decrease in mean systolic blood pressure less than 20% below baseline or less than 90 mmHg and intraoperative blood loss. Boluses of 200 ml of intravenous fluid will be administered until the above targets will be restored

Group Type ACTIVE_COMPARATOR

Standard fluid therapy

Intervention Type OTHER

Interventions

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Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided

Intervention Type PROCEDURE

Standard fluid therapy

Intervention Type OTHER

Other Intervention Names

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Esophageal doppler-Deltex Medical Intravenous infusion as recommended by international guidelines and anesthesia text-books

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing elective laparoscopic colorectal resection with an Enhanced Recovery Program

Exclusion Criteria

1. Age \<18 yr
2. Emergency surgery
3. Patients who do not understand, read or communicate in either French or English
4. Patients who had undergone esophageal or gastric surgery
5. Esophageal pathology (esophageal varices or cancer)
6. Patients with coarctation of the aorta or aortic stenosis
7. Chronic atrial fibrillation

7\. Preoperative bowel obstruction 8. Coagulopathies 9. Chronic use of opioids

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No