Clinical Trials Logo
  1. Home
  2. Perioperative Complication
  3. NCT04719884
  4. Details
NCT04719884 Clinical Trial

Fluid Optimisation in Laparoscopic Colorectal Procedures

Perioperative Complication Clinical Trial

Official title:
Fluid Optimisation in Laparoscopic Colorectal Procedures

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04719884
Other study ID # 127/5/12
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date September 1, 2018

Study information
Verified date January 2021
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date September 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients, undergoing elective laparoscopic colorectal surgery Exclusion Criteria: - Patients with cardiac arrhythmias

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Perioperative 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.

Locations
Country Name City State
Slovenia University Medical Centre Ljubljana Ljubljana

Sponsors (1)
Lead Sponsor Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Duration of hospitalisation 1 month after admission
Secondary Perioperative complications 8 days after surgery
See also
  Status Clinical Trial Phase
Recruiting NCT04602429 - Children's Acute Surgical Abdomen Programme
Completed NCT04167410 - Effect of Perioperative Glycemia Protocol on Glycemic Outcomes in Diabetic Patients Undergoing Abdominal Surgery N/A
Terminated NCT04506372 - Management of Angiotensin Inhibitors During the Perioperative Period N/A
Completed NCT04006106 - Defining ENDOtypes in Perioperative Hypersensitivity by Extensive Cellular and Molecular PHENotyping (ENDOPHEN)
Recruiting NCT06065137 - Standardised Drug Provocation Testing in Perioperative Hypersensitivity N/A
Completed NCT06203171 - Preoperative Evaluation on Perioperative Complications
Completed NCT04120324 - Incidence of 30 Day Return to Hospital Following Same Day Discharge Total Hip Arthroplasty
Not yet recruiting NCT06279000 - Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery Phase 3
Completed NCT02958293 - Perioperative Morbidity in Elective Surgery Based on the Time of the Year
Recruiting NCT04120012 - The Effect of Frailty to Perioperative Complications in the Elderly
Completed NCT04665349 - Effect of Fasting on the Non-invasive Measurement of the Body's Water Compartments N/A
Recruiting NCT04266574 - BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study N/A
Recruiting NCT04256798 - Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery Phase 3
Completed NCT04260334 - Preoperative Care In Ovarian Cancer Patients N/A
Recruiting NCT05533112 - Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia N/A
Completed NCT06097052 - Hypotension Predictive Index Effect on Intraoperative Hypotension During Pancreatic Surgery.
Recruiting NCT06035627 - The Effect of Inadvertent Perioperative Hypothermia on Surgical Site Infection in Laparoscopic Choleistectomy.
Not yet recruiting NCT06326528 - SGLT2 Inhibitors and Perioperative Period
Recruiting NCT04347772 - Effectiveness of Intensive Perioperative Nutrition Therapy Among Adults Undergoing Gastrointestinal & Oncology Surgery N/A
Completed NCT03974321 - Intraoperative Hypotension and Perioperative Myocardial Injury