UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010302 |
|---|---|
| Receipt number | R000007308 |
| Scientific Title | Analysis of a new liver retraction for laparoscopic surgery |
| Date of disclosure of the study information | 2013/03/22 |
| Last modified on | 2013/03/22 19:30:12 |
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Basic information
Public title
Analysis of a new liver retraction for laparoscopic surgery
Acronym
liver retractor for laparoscopic surgery
Scientific Title
Analysis of a new liver retraction for laparoscopic surgery
Scientific Title:Acronym
liver retractor for laparoscopic surgery
Region
| Japan |
Condition
Condition
gastric tumor
Classification by specialty
| Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is important for laparoscopic gastrectomy to retract the lateral segment of the liver to achieve the precise surgery and some of the liver retractor often leads transient liver dysfunction after surgery. For an easier and safer procedure, we invented a new liver retractor and induced it to clinical application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood was collected from the patients on day 1, 3 and 7 after surgery, examining the abnormal liver function.
Key secondary outcomes
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
Blood was collected from the patients on day 1, 3 and 7 after surgery, examining the abnormal liver function.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
over 20 years, male or female, those who had all agreed to participate after oral and written information.
Key exclusion criteria
The patients who were diagnosed as not eligible for this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisahiro Matsubara |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Frontier Surgery
Zip code
Address
1-8-1, Inohana, Chu-ou-ku, Chiba, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Frontier Surgery
Zip code
Address
TEL
043-226-2110
Homepage URL
Sponsor or person
Institute
Frontier Surgery, Chiba University graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Frontier Surgery, Chiba University graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 03 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 10 | Day |
Date trial data considered complete
| 2011 | Year | 01 | Month | 11 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 22 | Day |
Last modified on
| 2013 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007308
