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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023829
Receipt No. R000027452
Scientific Title Laparoscopic radical hysterectomy
Date of disclosure of the study information 2016/08/29
Last modified on 2018/02/20

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Basic information
Public title Laparoscopic radical hysterectomy
Acronym Laparoscopic radical hysterectomy
Scientific Title Laparoscopic radical hysterectomy
Scientific Title:Acronym Laparoscopic radical hysterectomy
Region
Japan

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

Objectives
Narrative objectives1 Cervical cancer operation shifts from laparotomy to laparoscopy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes intra-postoperative complication rate
Key secondary outcomes overall survival

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 surgery
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 cancer
stage IA2, IB1, IIA1
Key exclusion criteria cervical cancer
stage more than IA2, IB1, IIA1
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriomi Matsumura
Organization Kinki University Faculty of Medicine
Division name Department of Obstetrics & Gynecology
Zip code
Address 377-2 Ohno-Higashi, Osakasayama, Osaka
TEL 072-366-0221
Email y-kotani@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Kotani
Organization Kinki University Faculty of Medicine
Division name Department of Obstetrics & Gynecology
Zip code
Address 377-2 Ohno-Higashi, Osakasayama, Osaka
TEL 072-366-0221
Homepage URL
Email y-kotani@med.kindai.ac.jp

Sponsor
Institute Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization Kinki 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
2016 Year 08 Month 29 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 09 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 09 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
2016 Year 08 Month 29 Day
Last modified on
2018 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027452

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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