Goal Directed Fluid Therapy and Postoperative Ileus

Study Overview
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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.

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.

Official Title
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Goal-directed Fluid Therapy and Postoperative Ileus After Elective Laparoscopic Colorectal Surgery Using an Enhanced Recovery Program: a Randomized Controlled Trial

Conditions
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Postoperative Ileus

Intervention / Treatment
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* Procedure: Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided
* Other: Standard fluid therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal Directed Fluid Therapy (GDFT)<br>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. | Procedure: Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided<br> <br> * Other names: Esophageal doppler-Deltex Medical;|
| Active Comparator: Standard Fluid Therapy<br>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 | Other: Standard fluid therapy<br> <br> * Other names: Intravenous infusion as recommended by international guidelines and anesthesia text-books;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary postoperative ileus (POI) | Patients will be considered having primary POI if at least one symptom, for each of the following criteria, will be reported: i. vomiting (+/- nausea) OR abdominal distension AND ii. Absence of passing gas/stool OR not tolerating oral diet. | participants will be followed for the duration of hospital stay, an expected average of 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative hemodynamic measurements | Systolic blood pressure; diastolic blood pressure; mean arterial blood pressure; heart rate; flow-time corrected (FTc); stroke distance (SD); Peak velocity (PV); stroke volume (SV); stroke index (SVI); cardiac output (CO); cardiac Index (CI) | Participants will be followed for the duration of hospital stay, an expected average of 3 days | 
| Intraoperative and postoperative fluids and blood products required |  | Participants will be followed for the duration of hospital stay, an expected average of 3 days | 
| Vasoactive agents required |  | Participants will be followed for the duration of hospital stay, an expected average of 3 days | 
| Urinary output |  | Participants will be followed for the duration of hospital stay, an expected average of 3 days | 
| Intraoperative and postoperative urinary output |  | Participants will be followed for the duration of hospital stay, an expected average of 3 days | 
| Intraoperative and Postoperative opioid consumption | Intraoperative opioid administration and postoperative opioid consumption | Participants will be followed for the duration of hospital stay, an expected average of 3 days | 
| Postoperative nausea and vomiting (PONV) |  | Participants will be followed for the duration of hospital stay, an expected average of 3 days | 
| Time spent out of bed |  | Participants will be followed for the duration of hospital stay, an expected average of 3 days | 
| Postoperative complications (Clavien Classification) |  | Participants will be followed for the duration of hospital stay, an expected average of 3 days | 
| Patients' weight |  | Participants will be followed for the duration of hospital stay, an expected average of 3 days | 
| Quality of surgical recovery score |  | Participants will be followed for the duration of hospital stay, an expected average of 3 days | 
| Readiness to be discharged | : according to the colorectal pathway, hospital discharge is planned on postoperative day 3. Patients will be discharged if afebrile, able to tolerate oral diet, pain is controlled (NRS < 4), and able to ambulate | Participants will be followed for the duration of hospital stay, an expected average of 3 days | 
| Length of hospital stay |  | Participants will be followed for the duration of hospital stay, an expected average of 3 days |