UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029461
Receipt No. R000033647
Scientific Title The evaluation for safety and efficacy of the robotic total hysterectomy using da Vinci surgical system
Date of disclosure of the study information 2017/10/07
Last modified on 2017/10/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The evaluation for safety and efficacy of the robotic total hysterectomy using
da Vinci surgical system
Acronym The evaluation for safety and efficacy of the robotic total hysterectomy using
da Vinci surgical system
Scientific Title The evaluation for safety and efficacy of the robotic total hysterectomy using
da Vinci surgical system
Scientific Title:Acronym The evaluation for safety and efficacy of the robotic total hysterectomy using
da Vinci surgical system
Region
Japan

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

Objectives
Narrative objectives1 The evaluation for safety and efficacy of the robotic total hysterectomy using
da Vinci surgical system
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes blood loss
Key secondary outcomes operation time,complications,
hospitalization,postsurgical pain

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 the robotic total hysterectomy using da Vinci surgical system
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 uterine cervical canncer,uteinr corpus cancer,atypical endometrial hyperplasia,myoma uteri and adenomyosis that requires surgery
Key exclusion criteria inappropriate cases for laparoscopic surgeries due to severe endometriosis,severe obesity, severe intraabdominal adhesion and other factors
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fuminori Kitada
Organization Suita Tokushukai Hospital
Division name Department of Obstetrics & Gynecology
Zip code
Address 1-21,Senriokanishi,Suita city,Osaka
TEL 06-6878-1110
Email fuminori.kitada@tokushukai.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fuminori Kitada
Organization Suita Tokushukai Hospital
Division name Department of Obstetrics & Gynecology
Zip code
Address 1-21,Senriokanishi,Suita city,Osaka
TEL 06-6878-1110
Homepage URL
Email fuminori.kitada@tokushukai.jp

Sponsor
Institute Suita Tokushukai Hospital
Institute
Department

Funding Source
Organization Suita Tokushukai Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 吹田徳洲会病院(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 07 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
2017 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 07 Day
Last modified on
2017 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033647

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.