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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032410
Receipt No. R000036027
Scientific Title The safety and efficacy of laparoscopic para-aortic lymph node dissection for Ovarian Cancer
Date of disclosure of the study information 2018/04/27
Last modified on 2018/04/27

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Basic information
Public title The safety and efficacy of laparoscopic para-aortic lymph node dissection for Ovarian Cancer
Acronym The safety and efficacy of laparoscopic para-aortic lymph node dissection for Ovarian Cancer
Scientific Title The safety and efficacy of laparoscopic para-aortic lymph node dissection for Ovarian Cancer
Scientific Title:Acronym The safety and efficacy of laparoscopic para-aortic lymph node dissection for Ovarian Cancer
Region
Japan

Condition
Condition Ovarian cancer
Classification by specialty
Obsterics and gynecology Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety, efficacy, postoperative complications and QOL of laparoscopic para-aortic lymph node dissection for patient with Ovarian Cancer stage 1 - 2.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety and efficacy
Key secondary outcomes adverse event and reccurence

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 laparoscopic para-aortic lymph node dissection
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
25 years-old <=
Age-upper limit
75 years-old >=
Gender Female
Key inclusion criteria Ovarian cancer stage 1-2.
Patients who have no desire to have more child.
Positive pelvic lymph node metastasis by diagnostic imaging.
Key exclusion criteria Obesity.
Severe endometriosis.
Patient with severe complication.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Kondo
Organization Mie University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-174, Edobashi, Tsu city, Mie, Japan
TEL 059-232-1111
Email eijikon@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Kondo
Organization Mie University Faculty of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-174, Edobashi, Tsu city, Mie, Japan
TEL 059-232-1111
Homepage URL
Email eijikon@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University Faculty of Medicine
Institute
Department

Funding Source
Organization Mie University Faculty of Medicine
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

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 27 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 05 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 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
2018 Year 04 Month 27 Day
Last modified on
2018 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036027

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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