Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Complications

Intervention / Treatment
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* Other: Goal directed fluid therapy
* Other: Liberal fluid therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 or over patients who underwent pancreaticoduodenectomy in 2015 or in 2017 Exclusion Criteria: patients whose patient record information is insufficient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pancreaticoduodenectomy in 2015<br>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<br>* Patients in 2015 got intraoperative fluid therapy in goal directed fluid therapy technique.<br>|
| Pancreaticoduodenectomy in 2017<br>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<br>* Patients in 2017 got liberal intraoperative fluid therapy influenced by their anaesthesiologist.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreaticoduodenectomy, Clavien-Dindo classification, pancreatic fistulas