Improvement of Fluid Balance in Patients Undergoing Surgery of the Colon and Rectum

Study Overview
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Brief Summary
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58 patients undergoing surgery of the large bowel are divided into two groups. The control group will receive standard care. The intervention group will receive standard care plus optimization of the blood circulation based on in- or decrease of the output of the heart. Between group differences are measured primarily by markers of intestinal damage in plasma and urine. Also CO2 pressure in the stomach lumen is measured (reflecting blood supply to the gut). The investigators hypothesize that the intervention group will have less intestinal damage, improved blood supply to the bowel and improved recovery of the operation compared to the control group.

Official Title
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Does Hemodynamic Optimization During and After Colorectal Surgery Result in Improved Intestinal Perfusion, Sustained Intestinal Barrier and Improved Postoperative Recovery?

Conditions
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Colorectal Carcinoma

Intervention / Treatment
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* Procedure: Goal-directed fluid optimization
* Other: Regimen based on expertise anaesthesist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing elective colorectal surgery with anastomosis; Minimum age 18 years; Giving informed consent. Exclusion Criteria: Other causes of intestinal damage: eg. IBD, occlusive disease; Steroid use; Esophageal varices and other esophageal disease; Aortic valve disease.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal-directed fluid optimization<br>Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase. | Procedure: Goal-directed fluid optimization<br>* Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.<br>|
| Other: Regimen based on expertise anaesthesist<br>Fluid regimen based on expertise anaesthesist | Other: Regimen based on expertise anaesthesist<br>* Fluid regimen based on expertise anaesthesist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Value of I-FABP | Intestinal-Fatty Acid Binding Protein (a marker of intestinal damage) is measured in plasma. The primary outcome measure is the difference in peak values of I-FABP between the control group and the intervention group. | 1 hour postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Intraoperative CO2 Gap | The CO2 gap (difference arterial pCO2 and pCO2 of the stomach lumen) reflects global intestinal perfusion status and is measured every 15 minutes intraoperatively and every 60 minutes during the first 8 hours postoperatively. Intraoperative measurements were averaged per individual patient, producing the average intraoperative CO2 gap. | Average intraoperative CO2 gap | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodynamic optimization, Enhanced recovery after surgery, Goal-directed fluid