UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033158 |
|---|---|
| Receipt number | R000037813 |
| Scientific Title | Retrospective study of anesthetic management at biliary atresia patients open surgery versus laparoscopic surgery |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2018/06/27 11:09:54 |
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Basic information
Public title
Retrospective study of anesthetic management at biliary atresia patients open surgery versus laparoscopic surgery
Acronym
Retrospective study of anesthetic management at biliary atresia patients open surgery versus laparoscopic surgery
Scientific Title
Retrospective study of anesthetic management at biliary atresia patients open surgery versus laparoscopic surgery
Scientific Title:Acronym
Retrospective study of anesthetic management at biliary atresia patients open surgery versus laparoscopic surgery
Region
| Japan |
Condition
Condition
Biliary atresia
Classification by specialty
| Hepato-biliary-pancreatic surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We retrospectively compared anesthesia management of patients undergoing laparoscopic Kasai portoenterostomy and those undergoing conventional Kasai portoenterostomy.
Espencialy intend to research intraoperative hyopothemia and bleeding
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The degree of hypothemia during operation
Key secondary outcomes
Intraoperative bleeding,operation time,total urine,total fluid,and perioperative complication.
Base
Study type
Observational
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
| 1 | days-old | <= |
Age-upper limit
| 100 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo an elective Kasai operation between April 2010 and September 2017
Key exclusion criteria
Exclusion criteria were(1)reoperation(including revision operation and hemostasis)(2)the patient was diagnosed as not having biliary atresia(3)informed consent not provided by the patients family
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimitoshi Nishiwaki |
Organization
Nagoya university
Division name
Department of anesthesiology
Zip code
Address
Aichi, Japan, 65 tsurumai-cho, syouwa-ku, Nagoya city, Aichi, Japan
TEL
0527442340
nishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehito Sato |
Organization
Nagoya university
Division name
Department of anesthesiology
Zip code
Address
Aichi, Japan, 65 tsurumai-cho, syouwa-ku, Nagoya city, Aichi, Japan
TEL
0527442340
Homepage URL
takesato@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study of laparoscopic kasai operation and open surgery.
Management information
Registered date
| 2018 | Year | 06 | Month | 27 | Day |
Last modified on
| 2018 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037813
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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