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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031943
Receipt No. R000036452
Scientific Title Exploratory of searching about laparoscopic para-aortic lymphadenectomy for the endometrial cancer
Date of disclosure of the study information 2018/03/28
Last modified on 2018/03/27

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Basic information
Public title Exploratory of searching about laparoscopic para-aortic lymphadenectomy for the endometrial cancer
Acronym laparoscopic para-aortic lymphadenectomy for the endometrial cancer
Scientific Title Exploratory of searching about laparoscopic para-aortic lymphadenectomy for the endometrial cancer
Scientific Title:Acronym laparoscopic para-aortic lymphadenectomy for the endometrial cancer
Region
Japan

Condition
Condition endometrial cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 safety
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Quantity of operative haemorrhage
Key secondary outcomes The desection lymph node number, lymph node metastasis rate, blood transfusion rate, intraoperative and postoperative complications, QOL, 3-year PFS, 5-year OS

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
Maneuver
Interventions/Control_1 laparoscopic surgery for endometrial cancer
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

Not applicable
Gender Female
Key inclusion criteria stage IB and II patients
preoperation diagnosis of the endometrial cancer
the adaptation of the open surgery
patients are older than 20 years old
PS is 0-2
Key exclusion criteria serious heart, cerebro-vascular disease
When aspirin or warfarin cannot discontinue the fixed period of time in patients taking a drug resulting in bleeding tendency
patients with a history of the radiation therapy to the abdomen
severe renal damage patients
severe liver damage patients
When we judge that it is inappropriate cases
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoko Kato
Organization Kyushu University Hospital
Division name Department of Obstetrics and Gynecology
Zip code
Address 3-1-1 maedashi higashiku fukuokashi fukuoka prefecture Japan
TEL 0926425395
Email kkato@med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Kodama
Organization Kyushu University Hospital
Division name Department of Obstetrics and Gynecology
Zip code
Address 3-1-1 maedashi higashiku fukuokashi fukuoka prefecture Japan
TEL 0926425395
Homepage URL
Email kkeisuke@gynob.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital

Department of Obstetrics and Gynecology
Institute
Department

Funding Source
Organization Kyushu University Hospital

Department of Obstetrics and Gynecology
Organization
Division
Category of Funding Organization Self funding
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 九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 28 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
It passes without complications during the art of all three cases
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 Completed
Date of protocol fixation
2017 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information we will give a presentation at the meeting in future

Management information
Registered date
2018 Year 03 Month 28 Day
Last modified on
2018 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036452

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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