Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy

Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy - How to Reduce Postoperative Complications

Postoperative complication rates in patients undergoing pancreaticoduodenectomy remain high although the operation techniques have developed a lot in recent years. There is evidence that restrictive intraoperative fluid therapy could decrease postoperative complication rates but the results of the former studies have been somewhat controversial. The aim of this study is to examine whether the intraoperative and postoperative fluid therapy affect to the postoperative complication rates in patients undergoing pancreaticoduodenectomy.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications
• Intervention / Treatment: Other: Goal directed fluid therapy; Other: Liberal fluid therapy

Detailed Description

The study is a retrospective cohort study. The first cohort consists of patients who underwent pancreaticoduodenectomy in year 2015 when intraoperative fluid therapy were managed using goal directed fluid therapy technique. The second cohort consists of patients who underwent pancreaticoduodenectomy in year 2017 when intraoperative fluid therapy were based on the consideration of the anaesthesiologist. In 2015 most of the patients spent the first postoperative night in the ICU where the fluid management and monitoring of the urine output and vital functions were more controlled than in the normal ward. In 2017 most of the patients got in the regular ward right after the surgery. The aim of the study is to examine whether there are differences in the amounts of the intraoperative and postoperative fluids between the cohorts and does the perioperative fluid therapy affect to the complication rates.

• Study Type: Observational
• Enrollment (Actual): 168

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients who have underwent pancreaticoduodenectomy in years 2015 and 2017 are counted in the study.

Description

Inclusion Criteria:

• age 18 or over
• patients who underwent pancreaticoduodenectomy in 2015 or in 2017

Exclusion Criteria:

• patients whose patient record information is insufficient

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pancreaticoduodenectomy in 2015; Patients who underwent pancreaticoduodenectomy in 2015 got intraoperative fluid therapy in goal directed fluid therapy technique. Most of the patients spent the first postoperative night in ICU where the monitoring of urine output and fluid balance are more specific than in a normal ward.	Other: Goal directed fluid therapy; Patients in 2015 got intraoperative fluid therapy in goal directed fluid therapy technique.
Pancreaticoduodenectomy in 2017; Patients who underwent pancreaticoduodenectomy in 2017 got liberal intraoperative fluid therapy and most of the patients spent the first postoperative night in a regular ward.	Other: Liberal fluid therapy; Patients in 2017 got liberal intraoperative fluid therapy influenced by their anaesthesiologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative fluid volume	The amount of fluid (crystalloids and albumin) patients got during the surgery	The duration of the surgery
Postoperative complications (Clavien-Dindo classification)	The rate of severe Clavien-Dindo complications (3-5)	Postoperative day 0-30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe surgical complications	The rate of surgical complications (Clavien Dindo 3-5), without cardiopulmonary complications	Postoperative day 0-30
Cardiopulmonary complications	The rate of cardiopulmonary complications e.g., congestive heart failure, pleural effusion, dyspnea.	Postoperative day 0-30
Pancreatic fistulas	The rate of severe pancreatic fistulas (grade B-C)	Postoperative day 0-30
Postoperative fluid volume	The amount of fluid patients got postoperatively	Postoperative day 0-3
Intraoperative fluid balance	The change in intraoperative fluid intake (crystalloids, colloids, blood products) and fluid output (urine output, blood loss, evaporation) in millilitres and ml/kg.	The duration of the surgery
Postoperative fluid balance	The change in postoperative fluid intake (crystalloids, colloids, blood products) and fluid output (urine output, secretion in drains etc.) in millilitres.	Postoperative day 1-3

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Piia Peltoniemi, M.D., Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): November 20, 2020

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: pancreaticoduodenectomy; Clavien-Dindo classification; pancreatic fistulas
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: GDFT1517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No