UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	examination of effectiveness and safety for robot-assisted laparoscopic radical hysterectomy (RALRH) for the patient with uterine cervical cancer
Title of the study (Brief title)	examination of RALRH for uterine cervical cancer
Region	Japan

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

Objectives
Narrative objectives1	Our purpose of this study is to assess the efficacy and safety of robot assisted laparoscopic radical hysterectomy for the patient of uterine cervical cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	blood loss
Key secondary outcomes	operative time consol time number of resected lymphnodes appropriateness of resected organ rate of transfusion urinary function complications

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	We perform robot-assisted laparoscopic radical hysterectomhy for the patient with uterin cervical cancer.
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	Uterine cervical cancer, stage IA2-IIB (FIGO criteria) Generally good status (Performance status 0-2) Be agreed by the patient
Key exclusion criteria	The condition of having severe complecation (for example coronary heart disease,arrythmia,diabetes,liver failure,renal failure,glaucoma)Possibility of infection Judged unsuitable by researchers
Target sample size	10

Research contact person
Name of lead principal investigator	Tsukuru Amano
Organization	Shiga medical university
Division name	obstetrics and gynecology
Address	Tsukinowacho Seta Ootsu City
TEL	0775482267
Email	tsukuru@belle.shiga-med.ac.jp

Public contact
Name of contact person	Tsukuru Amano
Organization	Shiga medical university
Division name	obstetrics and gynecology
Address	Tsukinowacho Seta Ootsu City
TEL	0775482267
Homepage URL
Email	tsukuru@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga medical university hospital
Institute
Department

Funding Source
Organization	Shiga medical university hospitalh
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	滋賀医科大学病院（滋賀県）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 25 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2020 Year 07 Month 31 Day
Date of closure to data entry	2022 Year 12 Month 31 Day
Date trial data considered complete	2023 Year 01 Month 01 Day
Date analysis concluded	2023 Year 12 Month 31 Day

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

Management information
Registered date	2015 Year 07 Month 14 Day
Last modified on	2019 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020932