- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03060408
Comparison of Fluid Requirements in Pancreatectomy: Laparotomy vs. Laparoscopy
February 21, 2017 updated by: JiWon Han, Seoul National University Bundang Hospital
Comparison of Intraoperative Basal Fluid Requirements in Distal Pancreatectomy - Laparotomy vs. Laparoscopy: A Retrospective Cohort Study
In this retrospective cohort study, the investigators reviewed and analyzed the electronic medical records of consecutive patients who underwent distal pancreatectomy either via laparotomy or laparoscopy.
Intraoperative fluid administration amount, postoperative complications, length of hospital stay, and readmission rate were evaluated.
The total fluid amounts were calculated using the sum of colloids multiplied by 1.5 or 2.0 and crystalloids.
Study Overview
Status
Completed
Conditions
Detailed Description
There has been recent progress in intraoperative fluid therapy.
However, little is known about intraoperative fluid therapy in laparoscopic surgery.
The purpose of this study is to determine whether there are differences in the basal fluid requirements during surgery between laparotomy and laparoscopic distal pancreatectomy.
This study analyzed the records between June 2006 and March 2016.
And 253 patients who underwent distal pancreatectomy via either laparotomy (73 patients) or laparoscopy (180 patients).
This study was based on a retrospective review and analysis of the electronic medical records.
The volume of intraoperative fluid administered, postoperative complications, length of hospital stay, and readmission rate were evaluated.
The total volume of fluids was calculated as the sum of the volume of crystalloid plus the volume of colloid multiplied by 1.5 or 2.0.
Study Type
Observational
Enrollment (Actual)
304
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
indication of distal pancreatectomy
Description
Inclusion Criteria:
- indication of distal pancreatectomy
Exclusion Criteria:
- transfusion
- ASA physical status over 4
- co-operate other surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
Open
Patients underwent open distal pancreatectomy
|
Laparoscopic
Patients underwent laparoscopic distal pancreatectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
intraoperatively administered fluid amounts
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
February 1, 2017
Study Registration Dates
First Submitted
January 31, 2017
First Submitted That Met QC Criteria
February 21, 2017
First Posted (Actual)
February 23, 2017
Study Record Updates
Last Update Posted (Actual)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 21, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B-1508-312-102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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