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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023867
Receipt No. 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

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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
Email 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
Email crc-kenkyu@nanpuh.or.jp

Sponsor
Institute Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026828

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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