UMIN-CTR Clinical Trial

Basic information
Public title	Robot-assisted laparoscopic surgery (da Vinci) for early stage of carcinoma of the corpus uteri
Acronym	Robot-assisted laparoscopic surgery (da Vinci) for early stage of carcinoma of the corpus uteri
Scientific Title	Robot-assisted laparoscopic surgery (da Vinci) for early stage of carcinoma of the corpus uteri
Scientific Title:Acronym	Robot-assisted laparoscopic surgery (da Vinci) for early stage of carcinoma of the corpus uteri
Region	Japan

Condition
Condition	early stage of carcinoma of the corpus uteri
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to introduce robot-assisted laparoscopic surgery, which is a minimally invasive medical treatment for patients with carcinoma of the corpus uteri, and to meet the institution standard (conducted 10 cases) where insurance medical treatment can be performed.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Establishment of safe and radically secured robot-assisted laparoscopic surgery for carcinoma of the corpus uteri.Evaluate at the end of 10 cases.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Robot surgery, one day
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	Endometrial cancer stage I
Key exclusion criteria	Patients who have radiation therapy in the upper abdomen. Patients who can not obtain consent for the operation. Patients who do not get approval at the robot-assisted surgery case review meeting.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Takao Middle name Last name Mikoshiba
Organization	Saiseikai Yokohamashi Tobu Hospital
Division name	Obstetrics and Gynecology
Zip code	2308765
Address	3-6-1,simosueyoshi,turumi-ku,yokohama,kanagawa,japan
TEL	045-576-3000
Email	t_mikoshiba@tobu.saiseikai.or.jp

Public contact
Name of contact person	1st name Takao Middle name Last name Mikoshiba
Organization	Saiseikai Yokohamashi Tobu Hospital
Division name	Obstetrics and Gynecology
Zip code	2308765
Address	3-6-1,simosueyoshi,turumi-ku,yokohama,kanagawa,japan
TEL	045-576-3000
Homepage URL
Email	t_mikoshiba@tobu.saiseikai.or.jp

Sponsor
Institute	Saiseikai Yokohamashi Tobu Hospital
Institute
Department

Funding Source
Organization	Saiseikai Yokohamashi Tobu Hospital
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	Saiseikai Yokohamashi Tobu Hospital
Address	3-6-1,simosueyoshi,turumi-ku,yokohama,kanagawa,japan
Tel	045-576-3000
Email	t_mikoshiba@tobu.saiseikai.or.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	済生会横浜市東部病院

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 03 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	Open public recruiting
Date of protocol fixation	2019 Year 07 Month 01 Day
Date of IRB	2019 Year 07 Month 01 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 07 Month 03 Day
Last modified on	2021 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042237