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Clinical Trials/NCT03169998
NCT03169998CompletedNot Applicable

The Effect of Goal-directed Fluid Therapy on Postoperative Complications in Patients Undergoing Laparoscopic Hepatobiliary or Pancreatic Surgery

Seoul National University Bundang Hospital1 site in 1 country375 target enrollmentStarted: January 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
375
Locations
1
Primary Endpoint
Wound complication

Study Overview

Brief Summary

  • It has been known that the recent application of a goal-directed fluid therapy (GDFT) to the intraoperative fluid infusion in patients contributes to decreasing the prevalence of postoperative complications and shortening the length of study in the intensive care unit as well as hospital stay compared with conventional methods.
  • Laparoscopic surgery is in a trend that its application is being expanded recently, but there has been no report on the application of GDFT to laparoscopic surgery so far.
  • To this end, this study aims to apply the intraoperative GDFT protocol in patients undergoing laparoscopic hepatobiliary or pancreatic surgery and to find out whether there is any difference in postoperative recovery and incidences of postoperative complications, by comparing with patients applied with the fluid therapy using existing conventional methods

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Other

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Laparoscopic hepatobiliary or pancreatic surgery

Exclusion Criteria

  • Patients who do not consent to participation in the study
  • Pregnant women, breastfeeding women

Outcomes

Primary Outcomes

Wound complication

Time Frame: Postoperative 90 day

Deep vein thrombosis

Time Frame: Postoperative 90 day

Myocardiac infarction

Time Frame: Postoperative 90 day

Delirium

Time Frame: Postoperative 90 day

Death

Time Frame: Postoperative 90 day

Pulmonary complication

Time Frame: Postoperative 90 day

Acute kidney injury

Time Frame: Postoperative 90 day

Sepsis

Time Frame: Postoperative 90 day

Urinary tract infection

Time Frame: Postoperative 90 day

Stroke

Time Frame: Postoperative 90 day

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hyo-Seok Na

Clinical professor

Seoul National University Bundang Hospital

Study Sites (1)

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