UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013705 |
|---|---|
| Receipt number | R000015999 |
| Scientific Title | Evaluation of a perioperative management method for the purpose of fast postoperative recovery |
| Date of disclosure of the study information | 2014/04/20 |
| Last modified on | 2024/03/29 09:48:14 |
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Basic information
Public title
Evaluation of a perioperative management method for the purpose of fast postoperative recovery
Acronym
Perioperative management evaluation
Scientific Title
Evaluation of a perioperative management method for the purpose of fast postoperative recovery
Scientific Title:Acronym
Perioperative management evaluation
Region
| Japan |
Condition
Condition
Esophageal Cancer
Classification by specialty
| Gastrointestinal surgery | Anesthesiology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Achievement of rehabilitation (walking distance), the nutrient state of the day 30 post hospital discharge, postoperative complications, length of hospital stay, the total amount of fluids administered intra- and postoperatively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Speed of the postoperative recovery of gastro-intestinal function (daily observation of movement of the contrast agent on a gastrography).
Key secondary outcomes
Achievement of rehabilitation (walking distance), the nutrient state of the day 30 post hospital discharge, postoperative complications, length of hospital stay, the total amount of fluids administered intra- and postoperatively.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
When Stroke Volume Index (SVI) value stays in the range of +/- 10% or the target value, though blood pressure decreases, vasopressor is to be administered.When SVI value decreases by more than 10% of its target value, inotrope or vasodilator are to be administered.When SVI increased by more than 10% of its target value, diuretics is to be administered.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. ASA-PS class is I or II
2. Patients undergo esophagectomy
3. Patients who can sign the consent form by him/herself.
Key exclusion criteria
1.Patients with disease histories of ischemic heart disease and/or ischemic brain injury
2.Patients with coagulopathy and/or renal dysfunction
3.Pateints who need blood transfusion preoperatively
4.Patients who have difficulty in walking preoperatively
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Taniguchi |
Organization
Kanagawa University of Human Services
Division name
Faculty of Health and Human services
Zip code
Address
Heisei-Cho 1-10-1, Yokosuka, Kanagawa, Japan 238-8522
TEL
+81-46-828-2500
hstani@aol.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Taniguchi |
Organization
Kanagawa University of Human Services
Division name
Faculty of Health and Human services
Zip code
Address
Heisei-Cho 1-10-1, Yokosuka
TEL
+81-46-828-2500
Homepage URL
hstani@aol.jp
Sponsor or person
Institute
Kanagawa University of Human Services
Institute
Department
Personal name
Funding Source
Organization
Kanagawa University of Human Services
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Kanagawa Cancer Center
Name of secondary funder(s)
Edwards Lifesciences Limited
IRB Contact (For public release)
Organization
Address
Tel
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
神奈川県立がんセンター
神奈川県立保健福祉大学
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 20 | 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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015999
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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