Fluid Optimisation in Laparoscopic Colorectal Procedures

Study Overview
=================
Brief Summary
-----------------
Goal-directed fluid therapy (GDFT) with hemodynamic monitoring may not be of benefit to all elective patients undergoing major abdominal surgery, particularly those managed in Enhanced Recovery After Surgery protocols (ERAS) setting.

Detailed Description
-----------------
Our study compared two groups of patients undergoing elective laparoscopic colorectal surgery: a control group (CG) in which standard haemodynamic monitoring was used, and a study group (SG) in which extended haemodynamic monitoring was applied with appropriate intraoperative interventions. Differences in intraoperative fluid management, hospital stay, and postoperative morbidity were observed.

Official Title
-----------------
Fluid Optimisation in Laparoscopic Colorectal Procedures

Conditions
-----------------
Perioperative Complication

Intervention / Treatment
-----------------
* Procedure: Perioperative fluid optimisation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients, undergoing elective laparoscopic colorectal surgery Exclusion Criteria: Patients with cardiac arrhythmias

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Standard perioperative anesthesia management | |
| Active Comparator: Study group<br>Perioperative extended haemodynamic monitoring of fluid loading, cardiac output and changes of peripheral vascular resistance by analysing the arterial curve was provided by non-invasive haemodynamic monitoring (LIDCO Rapid, Lidco Ltd., United Kingdom).In SG fluid optimisation was performed before pneumoperitoneum and after abdominal desuflation with actions to achieved CI, MAP and SI within 80% of baseline values. | Procedure: Perioperative fluid optimisation<br>* In case of stroke volume variation (SVV) >10% and SI and CI >10% below the starting value, fluid challenge was performed with approximately 2 ml/kg of colloid over maximum of 5 minutes. The response was monitored. If there was a fall in SVV and an increase in SI of >10% and the SVV still >10%, the second fluid challenge was performed. If there was still a reduction in SVV after the second fluid challenge, but an increase in nSI <10% and decrease in systemic vascular resistance (SVR), no additional fluids were given. Vasoactive drugs were used instead.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalisation |  | 1 month after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative complications |  | 8 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative complications, intraoperative monitoring, haemodynamic monitoring, laparoscopic abdominal surgery