Fluid Optimisation in Laparoscopic Colorectal Procedures

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04719884

Enrollment

Registered

2021-01-22

Start date

2017-06-01

Completion date

2018-09-01

Last updated

2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Complication

Keywords

postoperative complications, intraoperative monitoring, haemodynamic monitoring, laparoscopic abdominal surgery

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.

Interventions

PROCEDUREPerioperative fluid optimisation

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients, undergoing elective laparoscopic colorectal surgery

Exclusion criteria

* Patients with cardiac arrhythmias

Design outcomes

Primary

Measure	Time frame
Duration of hospitalisation	1 month after admission

Secondary

Measure	Time frame
Perioperative complications	8 days after surgery

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026