UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of utility and safety for robot-assisted laparoscopic radical hysterectomy using da Vinci surgical system
Title of the study (Brief title)	robot-assisted laparoscopic radical hysterectomy
Region	Japan

Condition
Condition	Uterine cervical cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The object of this study is to assess the utility and safety of robot-assisted laparoscopic radical hysterectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	success operation rate using robot surgical system
Key secondary outcomes	intra- and post- operative complications relapse-free survival over-all survival postoperative QOL

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
Interventions/Control_1	robot-assisted laparoscopic radical hysterectomy
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 Uterine cervical cancer, stage IA2, IB1, 2A1 #2 Good general status (performance status 0-1)
Key exclusion criteria	#1 With active double cancers #2 With an obvious lymph node swelling(short diameter>10mm) #3 With an enlarged uterus which is needed for morcerllation #4 With a history of major abdominal surgery #5 With a history of radiotherapy for pelvis #6 With an angle-closure glaucoma
Target sample size	10

Research contact person
Name of lead principal investigator	SHOJI KAMIURA
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Gynecology
Address	1-3-3 Nakamichi, Higasinari-ku, Osaka
TEL	06-6972-1181
Email	kamiura-sh@mc.pref.osaka.jp

Public contact
Name of contact person	SHOJI KAMIURA
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Gynecology
Address	1-3-3 Nakamichi, Higasinari-ku, Osaka
TEL	06-6972-1181
Homepage URL
Email	kamiura-sh@mc.pref.osaka.jp

Sponsor
Institute	Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
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	2017 Year 01 Month 05 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 06 Month 17 Day
Anticipated trial start date	2017 Year 01 Month 05 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	2017 Year 01 Month 03 Day
Last modified on	2018 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029346