UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Total laparoscopic sacrocolpopexy for patients with pelvic organ prolapse
Title of the study (Brief title)	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	Osamu Hiraike
Organization	The University of Tokyo
Division name	Obstetrics and Gynecology
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	Osamu Hiraike
Organization	The University of Tokyo
Division name	Obstetrics and Gynecology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000015010