UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012859 |
|---|---|
| Receipt number | R000015010 |
| Scientific Title | Total laparoscopic sacrocolpopexy for patients with pelvic organ prolapse |
| Date of disclosure of the study information | 2014/01/15 |
| Last modified on | 2017/07/19 10:29:13 |
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Basic information
Public title
Total laparoscopic sacrocolpopexy for patients with pelvic organ prolapse
Acronym
Total laparoscopic sacrocolpopexy for patients with pelvic organ prolapse
Scientific Title
Total laparoscopic sacrocolpopexy for patients with pelvic organ prolapse
Scientific Title:Acronym
Total laparoscopic sacrocolpopexy for patients with pelvic organ prolapse
Region
| Japan |
Condition
Condition
pelvic organ prolapse
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We test the safety and efficacy of laparoscopic sacrocolpopexy for patients with pelvic organ prolapse.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of POP-Q staging, amount of hemorrhage during the procedure
Key secondary outcomes
presence of intra- and post-surgical complications, Values of hemoglobin, whtie blood cell count and CRP, Duration and extent of fever,
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
We evaluate the efficacy and safety of laparoscopic sacrocolpopexy for patients with pelvic organ prolapse.
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
Patients possessing pelvic organ prolapse (
more than stage III of POP-Q stage) are included in this study and their age should be less than 80.
They should be without life-threatning complications and hope this surgery.
Uteri should be smaller than new-born infant and can be managed by laparoscopy.
It should be demanded to obtain written informed consent.
Key exclusion criteria
Patients possessing adhesion around the uterus and having difficulties to perform the designed operation.
Those who can not understand the meaning and explanation of this surgery.
Other patients that are supposed to be inadequate to enroll this study.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Hiraike |
Organization
The University of Tokyo
Division name
Obstetrics and Gynecology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
wada-gyn@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Hiraike |
Organization
The University of Tokyo
Division name
Obstetrics and Gynecology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
wada-gyn@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo
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
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
| 2014 | Year | 01 | Month | 15 | 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
| 2013 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 15 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 15 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 15 | Day |
Last modified on
| 2017 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015010
