UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029924 |
|---|---|
| Receipt number | R000034186 |
| Scientific Title | Robot-assisted Sacrocolpopexy |
| Date of disclosure of the study information | 2018/01/10 |
| Last modified on | 2020/05/13 14:43:49 |
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Basic information
Public title
Robot-assisted Sacrocolpopexy
Acronym
Robot-assisted Sacrocolpopexy
Scientific Title
Robot-assisted Sacrocolpopexy
Scientific Title:Acronym
Robot-assisted Sacrocolpopexy
Region
| Japan |
Condition
Condition
Pelvic organ prolapse
Classification by specialty
| Obstetrics and Gynecology | Urology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of robot-assisted sacrocolpopexy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complication rate
Key secondary outcomes
blood loss, operative time, urinary function, defecation function, recurrence rate, reoperation rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
robot assisted sacrocolpopexy
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
ASA class 2 or below
ECOG PS 1 or below
age 20-
BMI 35kg/m2 or below
Key exclusion criteria
uncontrolled obstructive glaucoma
history of lower abdominal operation (excluding appendectomy or inguinal hernia)
history of lower abdominal irradiation
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Ishida |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Department of Urology
Zip code
230-8765
Address
3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Japan
TEL
045-576-3000
m_ishida@tobu.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Ishida |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Department of Urology
Zip code
230-8765
Address
3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Japan
TEL
045-576-3000
Homepage URL
m_ishida@tobu.saiseikai.or.jp
Sponsor or person
Institute
Saiseikai Yokohamashi Tobu Hospital
Institute
Department
Personal name
Funding Source
Organization
Saiseikai Yokohamashi Tobu 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
Ethical Committee of Saiseikai Yokohamashi Tobu Hospital
Address
3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Japan
Tel
045-576-3000
f_sawa@tobu.saiseikai.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
| 2018 | Year | 01 | Month | 10 | 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
| 2018 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 10 | Day |
Last modified on
| 2020 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034186
