PancreatectomyNCT03060408
Comparison of Fluid Requirements in Pancreatectomy: Laparotomy vs. Laparoscopy
An observational study of Pancreatectomy and Fluid Therapy, run by Seoul National University Bundang Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatectomy, Fluid Therapy, Laparoscopy
- How many people
- 304 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: indication of distal pancreatectomy
Who may be able to join
- indication of distal pancreatectomy
Who cannot join
- transfusion
- ASA physical status over 4
- co-operate other surgery
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatectomy, Fluid Therapy, Laparoscopy
- Keywords
- Fluid Therapy, Laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Open | Patients underwent open distal pancreatectomy | |
| Laparoscopic | Patients underwent laparoscopic distal pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperatively administered fluid amounts
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startJun 2016
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatectomyStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JiWon Han, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060408
- Sponsor's protocol ID
- B-1508-312-102
- Status last verified
- Feb 2017
- First submitted
- 31 Jan 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraoperative Basal Fluid Requirements in Distal Pancreatectomy - Laparotomy vs. Laparoscopy: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03060408
- Acronym / sponsor ID
- B-1508-312-102
- Conditions
- Pancreatectomy, Fluid Therapy, Laparoscopy
- Keywords
- Fluid Therapy, Laparoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open | – | –Patients underwent open distal pancreatectomy |
| Laparoscopic | – | –Patients underwent laparoscopic distal pancreatectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- indication of distal pancreatectomy
Key inclusion criteria (1 listed)
- indication of distal pancreatectomy
Key exclusion criteria (3 listed)
- transfusion
- ASA physical status over 4
- co-operate other surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
intraoperatively administered fluid amounts
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatectomy and Fluid Therapy, run by Seoul National University Bundang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperatively administered fluid amounts (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.