Clinical trial NCT04687826: Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy
Official title: Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy - How to Reduce Postoperative Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Keywords: pancreaticoduodenectomy
Clavien-Dindo classification
pancreatic fistulas
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who have underwent pancreaticoduodenectomy in years 2015 and 2017 are counted in the study.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* patients whose patient record information is insufficient

Primary outcomes:
measure: Intraoperative fluid volume
timeFrame: The duration of the surgery
measure: Postoperative complications (Clavien-Dindo classification)
timeFrame: Postoperative day 0-30
Secondary outcomes:
measure: Severe surgical complications
timeFrame: Postoperative day 0-30
measure: Cardiopulmonary complications
timeFrame: Postoperative day 0-30
measure: Pancreatic fistulas
timeFrame: Postoperative day 0-30
measure: Postoperative fluid volume
timeFrame: Postoperative day 0-3
measure: Intraoperative fluid balance
timeFrame: The duration of the surgery
measure: Postoperative fluid balance
timeFrame: Postoperative day 1-3
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Piia Peltoniemi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: