UMIN-CTR Clinical Trial

Basic information
Public title	the study of utility and safety for robot-assisted laparoscopic radical hysterectomy using da Vinci S surgical system
Acronym	the study of utility and safety for robot-assisted laparoscopic radical hysterectomy
Scientific Title	the study of utility and safety for robot-assisted laparoscopic radical hysterectomy using da Vinci S surgical system
Scientific Title:Acronym	the study of utility and safety for 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	"da Vinci S Surgical System" as robot assisted surgery device is safe, minimally invasive and stressless, so is suitable for complicated and delicate operation as radical hysterectomy. Our purpose of this study is to assess the utility and safety of this system for robot assisted laparoscopic radical hysterectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Intra-operative & post-operative complications
Key secondary outcomes	1. blood loss 2. the level of postoperative pain 3. the numaber of retrieved lymphnodes 4. operative time

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 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	70 years-old >=
Gender	Female
Key inclusion criteria	#1 Uterine cervical cancer, stage IA2-IIB (FIGO criteria) #2 Good general status (Performance status 0-1)
Key exclusion criteria	#1 With double cancers #2 With a history of pelvic radiotherapy #3 With a history of a surgery in the pelvis #4 Intolerant of general anesthesia #5 Undergoing chemotherapy #6 In pregnancy
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Tokunaga
Organization	Tohoku University Hospital
Division name	Gynecology
Zip code	980-8574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7254
Email	tokunagahideki@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Zen Middle name Last name Watanabe
Organization	Tohoku University
Division name	Gynecology
Zip code	980-8574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7254
Homepage URL
Email	zenw5261@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Tohoku University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee Tohoku University Hospital
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
Tel	022-728-4105
Email	rinri-2@proj.med.tohoku.ac.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

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 01 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	Enrolling by invitation
Date of protocol fixation	2014 Year 10 Month 01 Day
Date of IRB	2014 Year 09 Month 16 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 10 Month 01 Day
Last modified on	2021 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017274