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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016020
Receipt No. R000018627
Scientific Title The efficacy and eligibility of laparoscopic radical hysterectomy for early stage uterine cervical cancers
Date of disclosure of the study information 2015/03/01
Last modified on 2018/08/11

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Basic information
Public title The efficacy and eligibility of laparoscopic radical hysterectomy for early stage uterine cervical cancers
Acronym Laparoscopic radical hysterectomy
Scientific Title The efficacy and eligibility of laparoscopic radical hysterectomy for early stage uterine cervical cancers
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 Assess the efficacy and safety of laparoscopic radical hysterectomy to compare the following outcomes with conventional surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blood loss, blood transfusion, discharge date, postoperative complications such as ileus, SSI, and pain, surgical completion
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 1. laparoscopic PEN
2. followed by 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
70 years-old >
Gender Female
Key inclusion criteria 1)cervical cancer stage IA2, IB1, and IIA1
2)with written informed consent
Key exclusion criteria 1. anyone who does not satisfy inclusion criteria
2. PS>2, or with severe complications
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikuo KONISHI
Organization Kyoto University Graduate School of Medicine
Division name Gynecology and Obstetrics
Zip code
Address 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
TEL 075-751-3269
Email babatsu@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsukasa BABA
Organization Kyoto University Graduate School of Medicine
Division name Gynecology and Obstetrics
Zip code
Address 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
TEL 075-751-3269
Homepage URL
Email babatsu@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kyoto University Graduate School of Medicine
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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 01 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 Terminated
Date of protocol fixation
2014 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 02 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 LRH has been covered with health insurance since April 2018.

Management information
Registered date
2014 Year 12 Month 22 Day
Last modified on
2018 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018627

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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