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Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy

NCT ID: NCT04687826

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2020-11-20

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.

Conditions

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Postoperative Complications

Keywords

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pancreaticoduodenectomy Clavien-Dindo classification pancreatic fistulas

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pancreaticoduodenectomy in 2015

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.

Goal directed fluid therapy

Intervention Type OTHER

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

Pancreaticoduodenectomy in 2017

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.

Liberal fluid therapy

Intervention Type OTHER

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

Interventions

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Goal directed fluid therapy

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

Intervention Type OTHER

Liberal fluid therapy

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Piia Peltoniemi

M.D. Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Piia Peltoniemi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Other Identifiers

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GDFT1517

Identifier Type: -

Identifier Source: org_study_id