UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017029 |
|---|---|
| Receipt number | R000019689 |
| Scientific Title | The usefulness and safety study of robot assisted laparoscopic gastrectomy |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2017/10/04 15:33:34 |
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Basic information
Public title
The usefulness and safety study of robot assisted laparoscopic gastrectomy
Acronym
The usefulness and safety study of robot assisted laparoscopic gastrectomy
Scientific Title
The usefulness and safety study of robot assisted laparoscopic gastrectomy
Scientific Title:Acronym
The usefulness and safety study of robot assisted laparoscopic gastrectomy
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness and safety of robot assisted laparoscopic gastrectomy for gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of postoperative complication during 30 days after surgery.
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 | Maneuver |
Interventions/Control_1
Robot assisted laparoscopic 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed gastric cancer
2. Clinically diagnosed T1 or T2N0
3. Enough main organ functions to perform operation
4. To perform conventional laparoscopic gastrectomy safely
5. Patients aged 20 years and more
6. informed consent obtained from the patient
Key exclusion criteria
1. Remnant gastric cancer
2. Active multiple primary cancer
3. Patients with T3 and more. Patients with bulky lymph node metastasis.
4. Patients with severe intra-abdominal adhesion
5. Severe comobidities(ex: severe heart disease, plumonary disease, uncontrolable hypertension or diabetes)
6. Being pregnant
7. Severe psychiatric disease
8. Patients whom doctors consider unsuitable
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Rino |
Organization
Yokohama city university
Division name
Department of Surgery
Zip code
Address
3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, Japan
TEL
+81-45-787-2800
rino@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Sato |
Organization
Yokohama city university
Division name
Department of Surgery
Zip code
Address
3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, Japan
TEL
+81-45-787-2800
Homepage URL
t_sato@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university
Institute
Department
Personal name
Funding Source
Organization
Yokohama city university
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
| 2015 | Year | 06 | 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
| 2015 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | 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
Management information
Registered date
| 2015 | Year | 04 | Month | 02 | Day |
Last modified on
| 2017 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019689
