Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy

Completed

• Conditions: Postoperative Complications
• Interventions: Other: Liberal fluid therapy; Other: Goal directed fluid therapy

• Registration Number: NCT04687826
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2020-11-20
• Status Verified: 2020-12
• Study First Submitted: 2020-12-20
• Study First Submitted QC: 2020-12-28
• Last Update Submitted: 2020-12-28
• Study First Posted: 2020-12-29
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pancreaticoduodenectomy in 2017	Liberal fluid therapy	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.
Pancreaticoduodenectomy in 2015	Goal directed fluid therapy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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