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

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 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


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

Value
https://center6.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