UMIN-CTR Clinical Trial

Basic information
Public title	A study examining the safety and efficacy of robot-assisted surgery using the da Vinci Si system for patients with ureteropelvic junctionpart stenosis
Acronym	A study examining the safety and efficacy of robot-assisted surgery using the da Vinci Si system for patients with ureteropelvic junctionpart stenosis
Scientific Title	A study examining the safety and efficacy of robot-assisted surgery using the da Vinci Si system for patients with ureteropelvic junctionpart stenosis
Scientific Title:Acronym	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	1st name Atsuyuki Middle name Last name Yamataka
Organization	Juntendo University
Division name	Pediatric Surgery
Zip code	1138421
Address	2-1-1 Hongo Bunkyo-ku Tokyo
TEL	03-3813-3111
Email	yama@juntendo.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Murakami
Organization	Juntendo University
Division name	Pediatric Surgery
Zip code	1138421
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)

IRB Contact (For public release)
Organization	Hospital Ethics Committee Juntendo University Hospital
Address	3-1-3,Hongo,Bunkyo-ku,Tokyo
Tel	03-3813-3111
Email	kenkyu5858@juntendo.ac.jp

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

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	10
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	2017 Year 07 Month 03 Day
Date of IRB	2017 Year 08 Month 01 Day
Anticipated trial start date	2017 Year 07 Month 28 Day
Last follow-up date	2019 Year 03 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 02 Month 07 Day
Last modified on	2019 Year 06 Month 14 Day

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