Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy

NCT04687826 | Completed

• 1 other identifier: GDFT1517
• Study Type: observational
• Target: 168
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Complications

Keywords

pancreaticoduodenectomy; Clavien-Dindo classification; pancreatic fistulas

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Severe surgical complications

  Postoperative day 0-30

• Cardiopulmonary complications

  Postoperative day 0-30

• Pancreatic fistulas

  Postoperative day 0-30

• Postoperative fluid volume

  Postoperative day 0-3

• Intraoperative fluid balance

  The duration of the surgery

Study Arms (2)

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.

Other: Goal directed fluid therapy

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.

Other: Liberal fluid therapy

Interventions

Goal directed fluid therapy OTHER

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

Pancreaticoduodenectomy in 2015

Liberal fluid therapy OTHER

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

Pancreaticoduodenectomy in 2017

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who have underwent pancreaticoduodenectomy in years 2015 and 2017 are counted in the study.

You may qualify if:

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

You may not qualify if:

• patients whose patient record information is insufficient

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

MeSH Terms

Conditions

Postoperative Complications; Pancreatic Fistula

Condition Hierarchy (Ancestors)

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

Study Officials

• Piia Peltoniemi, M.D.

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Principal Investigator

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: December 29, 2020
• Study Start: January 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: November 20, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share