UMIN-CTR Clinical Trial

Basic information
Public title	The evaluation for safety and usefulness of the robotic assisted surgery using the da Vinci Si Surgical System.
Acronym	The evaluation for safety and usefulness of the robotic assisted surgery for uterine cancer.
Scientific Title	The evaluation for safety and usefulness of the robotic assisted surgery using the da Vinci Si Surgical System.
Scientific Title:Acronym	The evaluation for safety and usefulness of the robotic assisted surgery for uterine cancer.
Region	Japan

Condition
Condition	Uterine corpus cancer
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 usefulness of the robotic assisted surgery for uterine corpus cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Operation time, blood loss, complications, postsurgical pain, the rate of conversions to open surgery, the duration of hospitalization
Key secondary outcomes

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	Maneuver
Interventions/Control_1	Robotic assisted surgery ( total hysterectomy with bilateral salpingo-oophorectomy and pelvic lymphadenectomy)
Interventions/Control_2	Abdominal surgery ( total hysterectomy with bilateral salpingo-oophorectomy and pelvic lymphadenectomy)
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	uterine corpus cancer (endometrioid adenocarcinoma, FIGO IA and IB)
Key exclusion criteria	Inappropriate cases due to uterine cervical leiomyoma, severe obesity, severe intraabdominal adhesion and other factors
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toru Fujioka
Organization	Ehime University Graduate School of Medicine
Division name	Obstetrics and Gynecology
Zip code
Address	Shitsukawa, Toon, Ehime, Japan
TEL	089-960-5379
Email	fujioka@m.ehime-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Toru Fujioka
Organization	Ehime University Graduate School of Medicine
Division name	Obstetrics and Gynecology
Zip code
Address	Shitsukawa, Toon, Ehime, Japan
TEL	089-960-5379
Homepage URL
Email	fujioka@m.ehime-u.ac.jp

Sponsor
Institute	Ehime University Graduate School of Medicine, Department of Obstetrics and Gynecology
Institute
Department

Funding Source
Organization	Ehime University Hspital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2013 Year 11 Month 08 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
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	No longer recruiting
Date of protocol fixation	2013 Year 10 Month 21 Day
Date of IRB	2013 Year 10 Month 28 Day
Anticipated trial start date	2013 Year 11 Month 01 Day
Last follow-up date	2016 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 11 Month 08 Day
Last modified on	2020 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014321