Completed

Intraoperative GDFT vs SFT for Reduced Postoperative Ileus in Elective Laparoscopic Colorectal Surgeries with ERP

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What is being tested

Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided

+ Standard fluid therapy

ProcedureOther
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorGabriele Baldini, MD, MSc, Assistant Professor
Last updated: October 5, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01818375
Principal SponsorGabriele Baldini, MD, MSc, Assistant Professor
Last updated: October 5, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

128 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: All patients undergoing elective laparoscopic colorectal resection with an Enhanced Recovery Program Exclusion Criteria: Age <18 yr Emergency surgery Patients who do not understand, read or communicate in either French or English Patients who had undergone esophageal or gastric surgery Esophageal pathology (esophageal varices or cancer) Patients with coarctation of the aorta or aortic stenosis Chronic atrial fibrillation 7. Preoperative bowel obstruction 8. Coagulopathies 9. Chronic use of opioids

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Active Comparator
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Montreal General Hospital

Montreal, CanadaOpen Montreal General Hospital in Google Maps
CompletedOne Study Center