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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03060408
Other study ID # B-1508-312-102
Secondary ID
Status Completed
Phase N/A
First received January 31, 2017
Last updated February 21, 2017
Start date June 2016
Est. completion date February 2017

Study information

Verified date February 2017
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 304
Est. completion date February 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- indication of distal pancreatectomy

Exclusion Criteria:

- transfusion

- ASA physical status over 4

- co-operate other surgery

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary intraoperatively administered fluid amounts one year
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