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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000015312
Receipt No. R000017274
Scientific Title the study of utility and safety for robot-assisted laparoscopic radical hysterectomy using da Vinci S surgical system
Date of disclosure of the study information 2014/11/01
Last modified on 2020/04/06

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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
2021 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
2020 Year 04 Month 06 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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