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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000027713
Receipt No. R000031731
Scientific Title Laparoscopic radical hysterectomy for early stage cervical cancer
Date of disclosure of the study information 2017/07/01
Last modified on 2019/06/23

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Basic information
Public title Laparoscopic radical hysterectomy for early stage cervical cancer
Acronym Laparoscopic radical hysterectomy
Scientific Title Laparoscopic radical hysterectomy for early stage cervical cancer
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 Evaluation of the feasibility, safety, efficacy and oncological outcome of laparoscopic radical hysterectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pathological evaluation of resection margin
Three year disease-free survival
Key secondary outcomes Disease-free survival, three and five year survival, operation time, blood loss, blood transfusion rate, intraoperative complications, postoperative complications, postoperative quality of life

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 pelvic lymph node dissection
2)laparoscopic nerve-sparing 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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1)cervical cancer stage IA2,IB1,IIA1
2)with written informed consent
Key exclusion criteria 1)huge leiomyoma or adenomyosis
2)severe comorbidity
3)performance status 3 and 4
4)patients judged inappropriate for this study by the physician
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kentaro
Middle name
Last name Sekiyama
Organization Tazuke Kofukai Medical Research Institute Kitano Hospital
Division name Obstetrics and Gynecology
Zip code 530-8480
Address 2-4-20 Ohgimachi, Kita-ku, Osaka
TEL 06-6312-8831
Email k-sekiyama@kitano-hp.or.jp

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Kentaro
Organization Tazuke Kofukai Medical Research Institute Kitano Hospital
Division name Obstetrics and Gynecology
Zip code 530-8480
Address 2-4-20 Ohgimachi, Kita-ku, Osaka
TEL 06-6312-8831
Homepage URL
Email k-sekiyama@kitano-hp.or.jp

Sponsor
Institute Tazuke Kofukai Medical Research Institute Kitano Hospital
Institute
Department

Funding Source
Organization Tazuke Kofukai Medical Research Institute Kitano Hospital
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 Tazuke Kofukai Medical Research Institute Kitano Hospital
Address 2-4-20 Ohgimachi, Kita-ku, Osaka
Tel 06-6312-8831
Email rinshou@kitano-hp.or.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

Other administrative information
Date of disclosure of the study information
2017 Year 07 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 Suspended
Date of protocol fixation
2017 Year 06 Month 21 Day
Date of IRB
2017 Year 06 Month 21 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 09 Day
Last modified on
2019 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031731

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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