UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016703 |
|---|---|
| Receipt number | R000019384 |
| Scientific Title | Analysis of the surgical stress response by immediate vagotomy in laparoscopy-assisted total gastrectomy |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2023/09/11 07:13:06 |
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Basic information
Public title
Analysis of the surgical stress response by immediate vagotomy in laparoscopy-assisted total gastrectomy
Acronym
Analysis of the surgical stress response by immediate vagotomy in laparoscopy-assisted total gastrectomy
Scientific Title
Analysis of the surgical stress response by immediate vagotomy in laparoscopy-assisted total gastrectomy
Scientific Title:Acronym
Analysis of the surgical stress response by immediate vagotomy in laparoscopy-assisted total gastrectomy
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine if the surgical stress response is attenuated by immediate vagotomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative analysis of inflammatory cytokines in peripheral blood
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
the group treated by immediate vagotomy
Interventions/Control_2
the group treated by later vagotomy
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
The patient who will be received laparoscopy-assisted total gastrectomy due to gastric cancer.
The patient who will be achieved curative resection.
Key exclusion criteria
The patient who has been performed hemodialysis therapy.
The patient who will be required the resection of additional organs at the time of preoperative examinations.
The patient whom the doctor determine ineligible.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kimikazu |
| Middle name | |
| Last name | Hamano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Surgery and Clinical Science
Zip code
7550002
Address
1-1-1 Minamikogushi, Ube
TEL
0836222261
surg-1@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Eijiro |
| Middle name | |
| Last name | Harada |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Surgery and Clinical Science
Zip code
7550002
Address
1-1-1 Minamikogushi, Ube
TEL
0836222261
Homepage URL
eharada@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Department of Surgery and Clinical Science
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Graduate School of Medicine
Department of Surgery and Clinical Science
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
Yamaguchi University Graduate School of Medicine Department of Surgery and Clinical Science
Address
Minamikogushi 1-1-1, Ube
Tel
0836-22-2261
eharada@yamaguchi-u.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
| 2015 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2026 | 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
| 2015 | Year | 03 | Month | 04 | Day |
Last modified on
| 2023 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019384
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
