UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032297
Receipt No. R000036827
Scientific Title Clinical settingof robotic hysterectomy.
Date of disclosure of the study information 2018/04/18
Last modified on 2020/04/20

* 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 Clinical settingof robotic hysterectomy.
Acronym Clinical settingof robotic hysterectomy.
Scientific Title Clinical settingof robotic hysterectomy.
Scientific Title:Acronym Clinical settingof robotic hysterectomy.
Region
Japan

Condition
Condition benign uterine tumor
ensometrial cancer
cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We aimed to estabrish minimaly invasive and reliably executing a husterectomy with daVinci cystem.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blood loss
Key secondary outcomes operation time

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 operation
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
75 years-old >=
Gender Female
Key inclusion criteria 1. Patients were already diagnosed benign uterine tumor, endometrial cancer or cervical cancer.
2. Patients approve participation to the clinical research.
Key exclusion criteria 1. Patients with ineligible condition for robot assisted operation.
2. Patients who are not regarded appropriateness for robot assisted operation.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Satoru
Middle name
Last name Kyo
Organization Shimane University
Division name Obstetrics and Gynecology
Zip code 693-8501
Address Enyacho 89-1, Izumo, Shimane, Japan 6938501
TEL 0853-20-2268
Email satoruky@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Nakayama
Organization Shimane University
Division name Obstetrics and Gynecology
Zip code 693-8501
Address Enyacho 89-1, Izumo, Shimane, Japan 6938501
TEL 0853-20-2268
Homepage URL
Email kn88@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

Funding Source
Organization Shimane University
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 Bio Ethical Committee in Shimane University Hospital
Address Enyacho 89-1, Izumo, Shimane, Japan 6938501
Tel 0853-20-2515
Email kenkyu@med.shimane-u.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 島根大学病院

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 18 Day

Related information
URL releasing protocol https://rinken.shimane-u-tiken.jp/people/196
Publication of results Unpublished

Result
URL related to results and publications https://rinken.shimane-u-tiken.jp/people/196
Number of participants that the trial has enrolled 20
Results
The mean operating time of was short with in 6.5 hours in benign tumors and endometrial malignant tumors. In cervical malignant tumors, it was needed more than 6.5 hours, although anesthesists and responsible person of surgery made a judgmental decision and carried through surgery.In one case, estimated blood loss was massive and conversion to laparotomy.In other cases the mean estimated blood loss was very small amount and it was recognized the utility of robotic assisted surgery.
Results date posted
2020 Year 04 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
benign gynecological tumor 5 cases
malignant gynecological tumor 5 cases
Participant flow
All patients entered clinical trial arm. 
Adverse events
In one case, estimated blood loss were over 3000ml,so it was required blood transfusion  and conversion to laparotomy.
Outcome measures
mean estimated blood loss
benign gynecological tumor 115ml
malignant gynecological tumor 725ml

mean operation time
benign gynecological tumor 218min
malignant gynecological tumor 416min
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 04 Month 12 Day
Date of IRB
2013 Year 05 Month 27 Day
Anticipated trial start date
2013 Year 05 Month 12 Day
Last follow-up date
2019 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
2018 Year 04 Month 18 Day
Last modified on
2020 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036827

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.