UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040133 |
|---|---|
| Receipt number | R000045762 |
| Scientific Title | ERAS in pancreaticoduodenectomy: A meta-analysis of RCT |
| Date of disclosure of the study information | 2020/04/12 |
| Last modified on | 2020/04/12 11:18:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of an enhanced recovery after surgery protocol in pancreaticoduodenectomy: A meta-analysis of randomized controlled trials
Acronym
ERAS in pancreaticoduodenectomy: A meta-analysis of RCT
Scientific Title
ERAS in pancreaticoduodenectomy: A meta-analysis of RCT
Scientific Title:Acronym
ERAS in pancreaticoduodenectomy: A meta-analysis of RCT
Region
| Japan | Europe |
Condition
Condition
Patients undergoing pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the significance of enhanced recovery after surgery on short-term outcomes in pancreaticoduodenectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is short-term outcomes in pancreaticoduodenectomy
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were as follows:
patients undergoing pancreaticoduodenectomy; the assessment of ERAS; and postoperative ou
tcomes.
Key exclusion criteria
Records without abstracts, confer
ence abstracts, case reports, retrospective studies and reviews were excluded.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Kosei |
| Middle name | |
| Last name | Takagi |
Organization
Erasmus MC
Division name
Surgery
Zip code
3015 GD
Address
Dr. Molewaterplein 40,
TEL
+31643802627
k.takagi@erasmusmc.nl
Public contact
Name of contact person
| 1st name | Kosei |
| Middle name | |
| Last name | Takagi |
Organization
Erasmus MC
Division name
Surgery
Zip code
3015 GD
Address
Dr. Molewaterplein 40,
TEL
+31643802627
Homepage URL
k.takagi@erasmusmc.nl
Sponsor or person
Institute
Erasmus MC
Institute
Department
Personal name
Funding Source
Organization
Erasmus MC
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
+31643802627
k.takagi@erasmusmc.nl
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
| 2020 | Year | 04 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ethical approval: No ethical appro
val or informed consent statemen
t was required for this review arti
cle.
Management information
Registered date
| 2020 | Year | 04 | Month | 12 | Day |
Last modified on
| 2020 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045762
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
