UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness and safety of robotic surgery for uterine malignant tumors
Title of the study (Brief title)	Robotic surgery for uterine malignant tumors
Region	Japan

Condition
Condition	Uterine malignant tumor
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Comparison of efficacy and safety of robotic surgery with conventional laparotomy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Operation time and blood loss
Key secondary outcomes	Length of hospital stay, peri-operative complications and prognosis

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Robotic surgery
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	75 years-old >=
Gender	Female
Key inclusion criteria	patients with cervical cancer or endometrial cancer who have indications for radical surgery
Key exclusion criteria	glaucoma poor general condition
Target sample size	180

Research contact person
Name of lead principal investigator	Etsuko Miyagi
Organization	Yokohama City University Hospital
Division name	Obstetrics and Gynecology
Address	Fukuura 3-9, Kanazawaku, Yokohama city
TEL	045-787-2800
Email	emiygi@yokohama-cu.ac.jp

Public contact
Name of contact person	Etsukko Miyagi
Organization	Yokohama City University Hospital
Division name	Obstetrics and Gynecology
Address	Fukuura 3-9, Kanazawaku, Yokohama city
TEL	045-787-2800
Homepage URL
Email	emiygi@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University
Organization
Division
Category of Funding Organization	Local Government
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	2016 Year 06 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 07 Month 04 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 04 Month 20 Day
Date analysis concluded	2017 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 23 Day
Last modified on	2017 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017620