UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study for evaluating the utility and safety of robot-assisted gynecologic surgery using da Vinci Si surgical system
Title of the study (Brief title)	A clinical study for evaluating the utility and safety of robot-assisted gynecologic surgery
Region	Japan

Condition
Condition	cervical cancer, endometrial cancer, atypical endometrial hyperplasia, uterine myoma
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the utility and safety of robot-assisted surgery for gynecologic malignancies
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Anesthesia time, operative time, blood loss, intraoperative and postoperative complications, postoperative pain and hospital stay
Key secondary outcomes	Number of removed lymph nodes, postoperative levels of hemoglobin (Hb), white blood cells (WBC) and C-ractive proteins (CRP), and fever

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 surgery for gynecologic malignancies
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	70 years-old >=
Gender	Female
Key inclusion criteria	Atypical endometrial hyperplasia Endometrial cancer FIGO stage IA Cervical cancer FIGO stage IA1-IIB
Key exclusion criteria	Patients who are not recommended for laparoscopic surgery or study enrollment because of complications and other factors
Target sample size	20

Research contact person
Name of lead principal investigator	Toyomi Satoh
Organization	University of Tsukuba
Division name	Department of Obstetrics and Gynecology, Faculty of Medicine
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-3049
Email	toyomi-s@md.tsukuba.ac.jp

Public contact
Name of contact person	Hiroyuki Ochi
Organization	University of Tsukuba
Division name	Department of Obstetrics and Gynecology, Faculty of Medicine
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-3073
Homepage URL
Email	hochi@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba Hospital
Institute
Department

Funding Source
Organization	University of Tsukuba Hospital
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	筑波大学附属病院 (茨城県)

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 07 Month 09 Day
Anticipated trial start date	2014 Year 10 Month 01 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	2014 Year 07 Month 26 Day
Last modified on	2017 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017054