UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022351 |
|---|---|
| Receipt number | R000025716 |
| Scientific Title | Fluid management during laparoscopic upper gastrointestinal surgery |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2024/05/22 20:13:09 |
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Basic information
Public title
Fluid management during laparoscopic upper gastrointestinal surgery
Acronym
Fluid management during laparoscopic upper gastrointestinal surgery
Scientific Title
Fluid management during laparoscopic upper gastrointestinal surgery
Scientific Title:Acronym
Fluid management during laparoscopic upper gastrointestinal surgery
Region
| Japan |
Condition
Condition
Patients scheduled laparoscopic gastrointestinal surgery
Classification by specialty
| Gastrointestinal surgery | Anesthesiology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to test the restricted fluid therapy against the liberal fluid therapy on postoperative outcome undergoing laparoscopic upper gastorointestinal surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30-day postoperative complications
Key secondary outcomes
Ratio of extracellular water to total body water measured by bioimpedance analysis
Postoperative body weight
Length of hospital stay
Need for postoperative diuretic treatment
Postoperative hypotension
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients are randomized to either restricted fluid therapy or liberal fluid therapy.
Interventions/Control_2
Restricted fluid therapy group receive 1-2ml/kg/h of crystalloids. Hypotension (mean blood pressure < 60mmhg) is treated by administration of phenylephrine. If hypotension can not be treated, 200ml boluses of colloids (hydroxyethyl starch solutions) are given.
Liberal fluind therapy group receive 7-10mg/kg/h of crystalloids. Hypotension (mean blood pressure < 60mmhg) is treated by administration of phenylephrine.
Blood loss is replaced by colloids for both groups.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled laparoscopic upper gastrointestinal surgery
ASA physical status classification (1-3)
Key exclusion criteria
Patients who require hemodialysis
Patients who have a history of pacemaker implantation
Patients who required converting to open surgery
Patients whose intraoperative blood loss exceeded 500ml
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Minami |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
569-0801
Address
2-7 Daigaku-machi, Takatsuki, Osaka
TEL
+81-72-683-1221
ane063@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Kusaka |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
569-0801
Address
2-7 Daigaku-machi, Takatsuki, Osaka
TEL
+81-72-683-1221
Homepage URL
ane063@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical College Ethics Committee
Address
2-7 Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan
Tel
0726831221
rinri@osaka-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 18 | Day |
Last modified on
| 2024 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025716
