UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical study of robotic assisted gynecologic surgery using the da Vinci Si Surgical System.
Title of the study (Brief title)	The clinical study of robotic assisted gynecologic surgery using the da Vinci Si Surgical System.
Region	Japan

Condition
Condition	endometrial cancer, atypical endometrial hyperplasia, submucosal leiomyoma, endometrial polyp
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is the evaluation for safety and usefulness of robotic assisted surgery for gynecologic disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	operation time, blood loss.
Key secondary outcomes	aesthesia time, complications, postoperative pain-killer use frequency, duration of hospitalization.

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	Device,equipment Maneuver
Interventions/Control_1	robotic assisted gynecologic surgery (total hysterectomy, bilateral salpingo oophorectomy, pelvic lymphadenectomy)
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Female
Key inclusion criteria	1. endometrial cancer, atypical endometrial hyperplasia, submucosal leiomyoma, endometrial polyp. 2. In the case of endometrial cancer, clinical stage is FIGO IA and IB.
Key exclusion criteria	1. Patients with severe complications. 2. Patients who are judged to be inappropriate to carry out the study by the medical attendant.
Target sample size	20

Research contact person
Name of lead principal investigator	Yuji Takei
Organization	Jichi Medical University
Division name	Department of Obstetrics and Gynecology
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498 Japan
TEL	0285-58-7376
Email	ytakei@jichi.ac.jp

Public contact
Name of contact person	Yuji Takei
Organization	Jichi Medical University
Division name	Department of Obstetrics and Gynecology
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498 Japan
TEL	0285-58-7376
Homepage URL
Email	ytakei@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	Jichi Medical University Jichi Medical University Hospital
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

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 27 Day
Anticipated trial start date	2015 Year 03 Month 31 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	2015 Year 08 Month 22 Day
Last modified on	2018 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021710