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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020209
Receipt No. R000022928
Scientific Title The evaluation for usefulness of the laparoscopic radical hysterectomy
Date of disclosure of the study information 2015/12/15
Last modified on 2017/06/17

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Basic information
Public title The evaluation for usefulness of the laparoscopic radical hysterectomy
Acronym Usefulness of the laparoscopic radical hysterectomy
Scientific Title The evaluation for usefulness of the laparoscopic radical hysterectomy
Scientific Title:Acronym Usefulness of the laparoscopic radical hysterectomy
Region
Japan

Condition
Condition Uterine cervical cacner
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is the evaluation for effectivity of the laparoscopic radical hysterectomy for the uterine cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Occurrence of complication after operation and recurrence in 5 years
Key secondary outcomes

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 radical hysterectomy
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
80 years-old >
Gender Female
Key inclusion criteria Cervical cacner of stageIA2, IB1, and IIA1
Key exclusion criteria contraindication to the general operation
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Nishida
Organization Oita University
Division name Obstetrics and Gynecology
Zip code
Address 1-1 Idaigaoka Hasama-Machi Yufu-City Oita
TEL 097-586-5922
Email nishida@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masakazu Nishida
Organization Oita University
Division name Obstetrics and Gynecology
Zip code
Address 1-1 Idaigaoka Hasama-Machi Yufu-City Oita
TEL 097-586-5922
Homepage URL
Email nishida@oita-u.ac.jp

Sponsor
Institute Oita University
Institute
Department

Funding Source
Organization Oita University
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

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 15 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
2015 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 12 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

Management information
Registered date
2015 Year 12 Month 15 Day
Last modified on
2017 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022928

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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