UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035800 |
|---|---|
| Receipt number | R000040782 |
| 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 |
| Date of disclosure of the study information | 2019/02/07 |
| Last modified on | 2019/06/14 11:27:28 |
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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
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
hmuraka@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040782
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
