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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030440
Receipt No. R000015026
Scientific Title Safety and feasibility of robotic assisted hysterectomy
Date of disclosure of the study information 2017/12/17
Last modified on 2019/03/01

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Basic information
Public title Safety and feasibility of robotic assisted hysterectomy
Acronym Safety and feasibility of robotic assisted hysterectomy
Scientific Title Safety and feasibility of robotic assisted hysterectomy
Scientific Title:Acronym Safety and feasibility of robotic assisted hysterectomy
Region
Japan

Condition
Condition uterine disease
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of da Vinci surgical system as a tool for hysterectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes anesthesia tie, operation time, hemorrhage during procedure, frequency of use of analgesic agents, dates of hospital stay
Key secondary outcomes intra- and post-surgical complications, values of hemoglobin, white blood cell count and CRP, duration and extent of fever

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1) Those who possess uterine disorders including uterine fibroid, adenomyosis etc. and hope to be hysterectomized.
2) The uterine size should be smaller than new born head and the uterus can be excised by conventional laparoscopy.
3) Those who are able to obtain written informed consent.
Key exclusion criteria 1) Those who are are inadequate to participate in this study due to their complications.
2) Those who can not understand the purpose of this study, and unable to obtain written informed consent.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Osuga
Organization University of Tokyo
Division name Department of Obstetrics and Gynecology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5800-8657
Email yutakaos-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Hiraike
Organization University of Tokyo
Division name Department of Obstetrics and Gynecology
Zip code
Address 7-3-1 hongo, Bunkyo-ku, Tokyo
TEL 03-5900-8657
Homepage URL
Email osamuwh-tky@umin.ac.jp

Sponsor
Institute University of Tokyo
Institute
Department

Funding Source
Organization University of Tokyo
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 12 Month 17 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 17 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
2019 Year 10 Month 30 Day
Date trial data considered complete
2019 Year 10 Month 30 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information Observational study

Management information
Registered date
2017 Year 12 Month 17 Day
Last modified on
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015026

Research Plan
Registered date File name
2018/12/19 20181128.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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