Skip to main content
OpenTrials
Completed

NCT Number: NCT04687826

Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Complications Digestive System Diseases Digestive System Fistula Fistula Pancreatic Diseases Pancreatic Fistula Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patients whose patient record information is insufficient

Treatment and study plan

Goal directed fluid therapy

Other

Patients in 2015 got intraoperative fluid therapy in goal directed fluid therapy technique.

Liberal fluid therapy

Other

Patients in 2017 got liberal intraoperative fluid therapy influenced by their anaesthesiologist.

Primary outcomes

  1. Intraoperative fluid volume

    Time frame: The duration of the surgery

    The amount of fluid (crystalloids and albumin) patients got during the surgery

  2. Postoperative complications (Clavien-Dindo classification)

    Time frame: Postoperative day 0-30

    The rate of severe Clavien-Dindo complications (3-5)

Secondary outcomes

  1. Severe surgical complications

    Time frame: Postoperative day 0-30

    The rate of surgical complications (Clavien Dindo 3-5), without cardiopulmonary complications

  2. Cardiopulmonary complications

    Time frame: Postoperative day 0-30

    The rate of cardiopulmonary complications e.g., congestive heart failure, pleural effusion, dyspnea.

  3. Pancreatic fistulas

    Time frame: Postoperative day 0-30

    The rate of severe pancreatic fistulas (grade B-C)

  4. Postoperative fluid volume

    Time frame: Postoperative day 0-3

    The amount of fluid patients got postoperatively

  5. Intraoperative fluid balance

    Time frame: 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.

  6. Postoperative fluid balance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2020
First posted
Dec 29, 2020
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.