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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022146
Receipt No. R000025387
Scientific Title Examination for the acquisition of the facility criterion of laparoscopic surgery for renal malignant tumor (using supportive equipment for endoscopic surgery)
Date of disclosure of the study information 2016/05/02
Last modified on 2016/04/30

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Basic information
Public title Examination for the acquisition of the facility criterion of laparoscopic surgery for renal malignant tumor (using supportive equipment for endoscopic surgery)
Acronym Examination for the acquisition of the facility criterion of Da Vinci partial nephrectomy for renal cell carcinoma
Scientific Title Examination for the acquisition of the facility criterion of laparoscopic surgery for renal malignant tumor (using supportive equipment for endoscopic surgery)
Scientific Title:Acronym Examination for the acquisition of the facility criterion of Da Vinci partial nephrectomy for renal cell carcinoma
Region
Japan

Condition
Condition renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 In the medical fee revision at 2016 April, laparoscopic surgery for renal malignant tumor (using supportive equipment for endoscopic surgery) was approved. Because full-time physician with the medical treatment of the experience more than 10 cases of as facility criterion is required, we perform the Da Vinci partial nephrectomy of 10 cases in our school expenses.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes radical resection
renal function
Key secondary outcomes ischemic time
estimated blood loss
console time
operating time
complication

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
Maneuver
Interventions/Control_1 After the surgery, we follow-up 4 weeks.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients diagnosed with renal cell carcinoma cT1a, cN0, cM0.
Patients obtained the consent in writing.
Key exclusion criteria Patients with a previous treatment of ipsilateral partial nephrectomy.
Patients with severe heart or respiratory failure.
Patients with severe renal dysfunction.
Patients who physician has determined to be ineligible.

Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidehiro Kakizaki
Organization Asahikawa Medical College
Division name Renal and Urologic Surgery
Zip code
Address Midorigaoka higashi 2-1-1-1 asahikawa hokkaido Japan
TEL 0166-68-2533
Email gtamajp@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Gaku Tamaki
Organization Asahikawa Medical College
Division name Renal and Urologic Surgery
Zip code
Address Midorigaoka higashi 2-1-1-1 asahikawa hokkaido Japan
TEL 0166-68-2533
Homepage URL
Email gtamajp@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical College
Institute
Department

Funding Source
Organization Asahikawa Medical College
Organization
Division
Category of Funding Organization Other
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 05 Month 02 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 Preinitiation
Date of protocol fixation
2016 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 09 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
2016 Year 04 Month 30 Day
Last modified on
2016 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025387

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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