臨床研究等提出・公開システム

Date of registration	Mar. 15, 2019
Last modified on	Dec. 31, 2022
Trial ID	jRCTs032180286

Scientific Title	Robotic assisted pyeloplasty using da Vinci Surgical system Si/Xi for ureteropelvic junction stenosis in children.
Public Title	Robotic assisted pyeloplasty in children.

Completion date	Jan. 18, 2021
Result actual enrolment	7
Baseline Characteristics	Mean age at surgery was 7.4 years old (range 3-10). Ureteropelvic junction obstruction is 6 left and 1 right. Robotic-assisted pyeloplasty was performed
Participant flow	7 patients at our institution were registered into this study
Adverse events	There were no adverse events in this study
Outcome measures	< Primary endpoint > There were no adverse events. < Secondary endpoint > Mean operative time and Mean blood loss were 368 min (range 243-516) and 6 mL (range 1-15), respectively. Duration of hospital stay was mean 7 days (range 1-15)
Brief summary	Robotic-assisted pyeloplasty can be performed safely and successfully without any adverse events
Date of posting of results summaries	Dec. 31, 2022

Plan to share IPD	Yes
Plan description	Results on the robotic-assisted pyeloplasty plan to present on pediatric surgical meetings and publish on medical journal. These never include personal identifiable data.
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs032180286

Contact for Scientific Queries	Name	Yamataka Atsuyuki
	Affiliation	Juntendo University Hospital
	Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
	Telephone	+81-3-3813-3111
	E-mail	yama@juntendo.ac.jp
Contact for Public Queries	Name	Murakami Hiroshi
	Affiliation	Juntendo University Hospital
	Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
	Telephone	+81-3-3813-3111
	E-mail	hmuraka@juntendo.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Aug. 31, 2017
Actual date of first enrollment		Nov. 21, 2018
Target sample size		40
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Juntendo University Medical School Association Juntendo Medical Institute Pediatric Surgery / Childhood Urology and Orthopedic Surgery Pelvic ureteral transitional stenosis patients with surgery indications visited or hospitalized
	Exclusion Criteria	Patient who the researcher judged inappropriate as the subject
	Age Minimum	1age old over
	Age Maximum	15age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Ureteropelvic part stenosis
Intervention(s)		Use the da Vinci Surgical system when performing renal pelvic formation.
Primary Outcome(s)		Adverse event occurrence rate: At the time of approach, consider whether there is complication after intraoperative or postoperative. Transition to laparotomy or laparoscopic surgery, blood transfusion practice, organ damage, vascular injury, postoperative bleeding, postoperative infection, pulmonary infarction, gas embolism
Secondary Outcome(s)		1) Surgical results: operation time, bleeding volume 2) 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 Evaluation), hospitalization period 3) Pathological examination : presence or absence of malignancy in resected bile duct 4) Overall survival period existence of death, period from surgery to death

Name of Certified Review Board	Juntendo Hospital Certified Review Board
Address	3-1-3,Hongo,Bunkyo-ku,Tokyo 113-8431, Tokyo
Telephone	+81-3-5802-1584
E-Mail	crbjun@juntendo.ac.jp
Approval Status	Approval
Date of approval	Mar. 05, 2019

Secondary ID(s)	UMIN000035800
Issuing Authority	University hospital Medical Information Network Center (UMIN)

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Dec. 31, 2022	(this page)	Changes
3	Jan. 27, 2021	Detail	Changes
2	April. 16, 2019	Detail	Changes
1	Mar. 15, 2019	Detail

List of change history