UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023867 |
|---|---|
| Receipt number | R000026828 |
| Scientific Title | Study of the safety of a robot assisted operation using 'da Vinci Xi' for stomach and colorectal cancer. |
| Date of disclosure of the study information | 2016/08/31 |
| Last modified on | 2018/09/03 17:07:51 |
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Basic information
Public title
Study of the safety of a robot assisted operation using 'da Vinci Xi' for stomach and colorectal cancer.
Acronym
Study of the safety of a robot assisted operation using 'da Vinci Xi' for stomach and colorectal cancer.
Scientific Title
Study of the safety of a robot assisted operation using 'da Vinci Xi' for stomach and colorectal cancer.
Scientific Title:Acronym
Study of the safety of a robot assisted operation using 'da Vinci Xi' for stomach and colorectal cancer.
Region
| Japan |
Condition
Condition
stomach and colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Study of the safety of a robot assisted operation using 'da Vinci Xi' for stomach and colorectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Age, sex, height, weight, BMI, PS
2. Past medical history:Health history, operation history
3. laboratory test values
4. pathological classification associated tumor, number of lymph nodes harvested, venous invasion
5. Operative information
procedure, reconstruction method, anesthesia time, surgical time, operative bleeding loss, Lymph node dissection number, completed in robot-assisted laparoscopic surgery, the reason of unsuccessful completion
6. Intraoperative and postoperative stomach cancer complication
7. Intraoperative and postoperative colorectal cancer complication
8. presence or absence of post-operation treatment and relapse, post-operation treatment of a therapeutic regimen, survival period, the start time of oral ingestion after operation, postoperative length of stay
9. The number of robot-assisted implemented, analysis of the operation time
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A robot assisted operation using 'da Vinci Xi'
period of ntervention: 5 years
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 as being stomach and colorectal cancer
2. Pre-operation test diagnosed as stomach and colorectal cancer which can be resected curatively
3. Patients diagnosed as cannot be applied to ESD
4. ECOG performance status scale: 0 or 1, ASA: 1 or 2
5. Age <=20 years old to >=75
6. Written informed consent is obtained
Key exclusion criteria
1. Anemic condition (hemoglobin >10g/dl)
2. The patient who has active multiple cancers
3. Long-term administration of steroids
4. Patients with psychiatric diseases
5. With uncontrolled diabetes composition
6. With uncontrolled hypertension composition
7. With respiratory disorder that need continuous supply supplemental oxygen composition
8. With central nervous system disease composition (intracranial disease)
9. With glaucomatous composition
10. The patient who pose a risk for developing intracranial hypertension by head- tilt
Other conditions judged ineligible by physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Kitazono |
Organization
Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital
Division name
Surgery / Gastrointestinal surgery
Zip code
Address
14-3 Nagata-cho, Kagoshima-city, Japan
TEL
0992269111
m-kitazono@nanpuh.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | clinical research coordinater |
Organization
Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital
Division name
Clinical Research Support Office
Zip code
Address
14-3 Nagata-cho, Kagoshima-city, Japan
TEL
0992269111
Homepage URL
crc-kenkyu@nanpuh.or.jp
Sponsor or person
Institute
Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital
Institute
Department
Personal name
Funding Source
Organization
Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital
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
| 2016 | Year | 08 | Month | 31 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 07 | 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
| 2016 | Year | 08 | Month | 31 | Day |
Last modified on
| 2018 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026828
