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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012859
Receipt No. 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

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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
Obsterics 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
Email 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
Email wada-gyn@h.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015010

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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