UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030440
Receipt number R000015026
Scientific Title Safety and feasibility of robotic assisted hysterectomy
Date of disclosure of the study information 2017/12/17
Last modified on 2021/07/09 17:21:39

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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

Obstetrics 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 Yutaka
Middle name
Last name Osuga

Organization

University of Tokyo

Division name

Department of Obstetrics and Gynecology

Zip code

1138655

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 Osamu
Middle name
Last name Hiraike

Organization

University of Tokyo

Division name

Department of Obstetrics and Gynecology

Zip code

1138655

Address

7-3-1 hongo, Bunkyo-ku, Tokyo

TEL

03-5900-8657

Homepage URL


Email

osamuwh-tky@umin.ac.jp


Sponsor or person

Institute

University of Tokyo

Institute

Department

Personal name



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

The University of Tokyo

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

Tel

0358008657

Email

osamuwh-tky@umin.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

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

2021 Year 07 Month 09 Day



Link to view the page

Value
https://center6.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