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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035800
Receipt No. R000040782
Official scientific title of the study A study examining the safety and efficacy of robot-assisted surgery using the da Vinci Si system for patients with ureteropelvic junctionpart stenosis
Date of disclosure of the study information 2019/02/07
Last modified on 2019/02/07

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Basic information
Official scientific title of the study A study examining the safety and efficacy of robot-assisted surgery using the da Vinci Si system for patients with ureteropelvic junctionpart stenosis
Title of the study (Brief title) A study examining the safety and efficacy of robot-assisted surgery using the da Vinci Si system for patients with ureteropelvic junctionpart stenosis
Region
Japan

Condition
Condition Ureteropelvic junctionpart stenosis
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility and efficacy of robot-assisted laparoscopic pyeloplasty for ureteropelvic junction obstruction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse event occurrence rate:
presence or absence of complications at approach, intraoperative or postoperative.
Transition to laparotomy or laparoscopic surgery, blood transfusion practice, organ damage, vascular injury, postoperative bleeding, postoperative infection, pulmonary infarction, gas embolism.
Key secondary outcomes Surgical results: operation time, bleeding volume
Postoperative course: postoperative Vital Sign, urine volume, body temperature, drainage volume, leukocytes / CRP values on days 1, 3 and 5 postoperatively, postoperative pain (VAS: Visual Analog Scale), hospitalization period
Pathological examination: presence or absence of malignancy in resected bile duct
Overall survival period: existence of death, period from surgery to death

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Laparoscopic Group
Interventions/Control_2 Robotic group
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
1 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria The patients diagnosed as ureteropelvic junction obstruction in Juntendo University Hospital Department of Pediatric General and Urogenital Surgery.
Subjects aged 1 to 15 at the time of acquiring consent.
patient or familys whose informed consents to join this study are obtained by the written document.
Key exclusion criteria Patient who the research director judged unsuitable as a subject
Target sample size 40

Research contact person
Name of lead principal investigator Atsuyuki Yamataka
Organization Juntendo University
Division name Pediatric Surgery
Address 2-1-1 Hongo Bunkyo-ku Tokyo
TEL 03-3813-3111
Email yama@juntendo.ac.jp

Public contact
Name of contact person Hiroshi Murakami
Organization Juntendo University
Division name Pediatric Surgery
Address 2-1-1 Hongo Bunkyo-ku Tokyo
TEL 03-3813-3111
Homepage URL
Email hmuraka@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Juntendo University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 順天堂大学医学部附属順天堂医院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 07 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 07 Month 03 Day
Anticipated trial start date
2017 Year 07 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 02 Month 07 Day
Last modified on
2019 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040782

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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