UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017406 |
|---|---|
| Receipt number | R000020191 |
| Scientific Title | The efficacy and safety of total laparoscopic radical hysterectomy |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2017/05/24 10:53:50 |
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Basic information
Public title
The efficacy and safety of total laparoscopic radical hysterectomy
Acronym
Total laparoscopic radical hysterectomy
Scientific Title
The efficacy and safety of total laparoscopic radical hysterectomy
Scientific Title:Acronym
Total laparoscopic radical hysterectomy
Region
| Japan |
Condition
Condition
Early-stage cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficiency and safety of total laparoscopic radical hysterectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the complications during and after the operation, the amount of bleeding , the rate of blood transfusion, patients' quality of life after the operation
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
To perform radical hysterectomy laparoscoplically, not abdominally
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
| Not applicable |
Gender
Female
Key inclusion criteria
Twenty and more than twenty years olds women preoperatively diagnosed as stage IA2 to IIA1 cervical cancer
Key exclusion criteria
A patient who is not consistent with key inclusion criteria
A patient whose uterus needs morcellation for a vaginal extraction
A patient with severe condition unsuitable to general anesthesia
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Saito |
Organization
Yokohama City University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
3-9 Fukuura Kanazawa-ku Yokohama Kanagawa
TEL
045-787-2800
saitouk88@live.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Saito |
Organization
Yokohama City University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
3-9 Fukuura Kanazawa-ku Yokohama Kanagawa
TEL
045-787-2800
Homepage URL
saitouk88@live.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | 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
| 2015 | Year | 05 | Month | 03 | Day |
Last modified on
| 2017 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020191
