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Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04687826
Enrollment
168
Registered
2020-12-29
Start date
2015-01-01
Completion date
2020-11-20
Last updated
2020-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Keywords

pancreaticoduodenectomy, Clavien-Dindo classification, pancreatic fistulas

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.

Interventions

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

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

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* patients whose patient record information is insufficient

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative fluid volumeThe duration of the surgeryThe amount of fluid (crystalloids and albumin) patients got during the surgery
Postoperative complications (Clavien-Dindo classification)Postoperative day 0-30The rate of severe Clavien-Dindo complications (3-5)

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026