UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015388 |
|---|---|
| Receipt number | R000017904 |
| Scientific Title | Feasibility, safety, effectiveness, and economical efficiency of robotic gastrectomy for resectable gastric cancer: a multi-institutional historically controlled prospective cohort study |
| Date of disclosure of the study information | 2014/10/10 |
| Last modified on | 2014/10/09 18:02:14 |
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Basic information
Public title
Feasibility, safety, effectiveness, and economical efficiency of robotic gastrectomy for resectable gastric cancer: a multi-institutional historically controlled prospective cohort study
Acronym
Robotic gastrectomy for gastric cancer
Scientific Title
Feasibility, safety, effectiveness, and economical efficiency of robotic gastrectomy for resectable gastric cancer: a multi-institutional historically controlled prospective cohort study
Scientific Title:Acronym
Robotic gastrectomy for gastric cancer
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Morbidity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Postoperative complications greater than Grade III according to Clavien-Dindo classification
Key secondary outcomes
Postoperative Complications grater than Grade II according to Clavien-Dindo classification,
Health outcomes measured by EuroQol 5 Dimension (EQ-5D)
Total Medical Cost
Disease free survival
Robotic gastrectomy success rate
Conversion to laparotomy
Intraoperative adverse effects
Surgical outcomes
Postoperative courses
Surgery-Related Mortality
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
Robotic gastrectomy
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Operable patients under general anesthesia
Histologically diagnosed gastric adenocarcionoma
cStage I or II disease curably treated with total, distal, or proximal gastrectomy with D1+ or D2 lymph node dissection
Not indicated for endoscopic resection
Age over 18
Informed consent is obtained
Key exclusion criteria
Patients with mental disorders
Preoperative use of chemotherapy
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Uyama |
Organization
Fujita Health University
Division name
Division of Upper GI, Department of Surgery
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi 470-1192, Japan
TEL
0562-93-9254
iuyama@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuharu Hamano |
Organization
Fujita Health University Hospital
Division name
Medical office worker
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi 470-1192, Japan
TEL
0562-93-2025
Homepage URL
hamano@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2014 | Year | 10 | Month | 10 | 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 | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 09 | Day |
Last modified on
| 2014 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017904
