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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016501
Receipt No. R000019161
Scientific Title Laparoscopic radical hysterectomy
Date of disclosure of the study information 2015/02/10
Last modified on 2021/10/16

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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 To evaluate the feasibility, safety and oncological outcome of the laparoscopic radical hysterectomy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of resected specimen
3 yr disease free survival
Key secondary outcomes Diesease free survival
3,5yr survival
operation time
blood loss
transfuseon rate
intra-postoperative complication
post operative quality of life compared with the laparotomy

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
Laparoscopic radical hysterectomy
& pelvic lymphadenectomy
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1) cervical cancer
stage IA2,IB1,IIA1
Key exclusion criteria 1) huge leiomyoma or adenomayosis
2) severe comorbidity
3) performance status 3.4
4) patients judged inappropriate for this study by the physician
Target sample size 3

Research contact person
Name of lead principal investigator
1st name Masato
Middle name
Last name Kita
Organization Kansai Medical University
Division name Obstetrics and Gynecology
Zip code 573-1010
Address 2-5-1 Shinmachi, Hirakata Osaka 573-1010
TEL 0728040101
Email kitamas@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name Masato
Middle name
Last name Kita
Organization Kansai Medical University
Division name Obstetrics and Gynecology
Zip code 573-1010
Address 2-5-1 Shinmachi, Hirakata Osaka 573-1010
TEL 072-804-0101
Homepage URL
Email kitamas@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization Kansai Medical University
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 Kansai Medical University
Address Shinmachi 2-5-1, HIrakata City, Osaka, Japan
Tel 072-804-0101
Email kitamas@hirakata.kmu.ac.jp

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 関西医科大学

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 10 Day

Related information
URL releasing protocol none
Publication of results Unpublished

Result
URL related to results and publications none
Number of participants that the trial has enrolled 3
Results no complications
Results date posted
2021 Year 10 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics not paricular
Participant flow as scheduled
Adverse events none
Outcome measures no abnormal findings
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2014 Year 01 Month 19 Day
Date of IRB
2015 Year 02 Month 10 Day
Anticipated trial start date
2015 Year 02 Month 10 Day
Last follow-up date
2020 Year 02 Month 10 Day
Date of closure to data entry
2020 Year 02 Month 10 Day
Date trial data considered complete
2020 Year 02 Month 10 Day
Date analysis concluded
2020 Year 02 Month 10 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 10 Day
Last modified on
2021 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019161

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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