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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026701
Receipt No. R000030654
Scientific Title Intraocular pressure change during laparoscopic sacral colpopexy in patients with pelvic organ prolapse
Date of disclosure of the study information 2017/03/28
Last modified on 2018/12/16

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Basic information
Public title Intraocular pressure change during laparoscopic sacral colpopexy in patients with pelvic organ prolapse
Acronym Intraocular pressure change during laparoscopic sacral colpopexy
Scientific Title Intraocular pressure change during laparoscopic sacral colpopexy in patients with pelvic organ prolapse
Scientific Title:Acronym Intraocular pressure change during laparoscopic sacral colpopexy
Region
Japan

Condition
Condition pelvic organ prolapse
Classification by specialty
Obsterics and gynecology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to evaluate the Intraocular pressure in patients with pelvic organ prolapse during Laparoscopic sacral colpopexy(LSC) using the Trendelenburg position.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intraocula pressure change in LSC
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
30 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria the patients underwent laparoscopic sacral colpopexy in our institution
Key exclusion criteria glaucoma
cornea disease
followed by other ophthalmic clinic
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoji Moriyama
Organization Gifu Red Cross Hospital
Division name department of Urology
Zip code
Address 3-36 Iwakura-cho, Gifu-city, Gifu-pref.
TEL 0582312266
Email m-yoji@qc5.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoji Moriyama
Organization Gifu Red Cross Hospital
Division name department of Urology
Zip code
Address 3-36 Iwakura-cho, Gifu-city, Gifu-pref.
TEL 0582312266
Homepage URL
Email m-yoji@qc5.so-net.ne.jp

Sponsor
Institute Gifu Red Cross Hospital
Institute
Department

Funding Source
Organization Gifu Red Cross Hospital
Organization
Division
Category of Funding Organization Self funding
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 岐阜赤十字病院(岐阜県)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 28 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Intraocular pressure change during laparoscopic sacral colpopexy in patients with pre-existent eye diseases
The 11th Japanese Society of POP Surgery (JPOP) Annual Scientific Meeting,
 March 11Th-12th 2017 Tokyo, Japan
(the Academic Award of the poster presentation)

Intraocular Pressure Change during Laparoscopic Sacral Colpopexy in Patients with Normal Tension Glaucoma 
International Urogynecology Journal (in press)
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
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2018 Year 09 Month 25 Day
Date of closure to data entry
2018 Year 09 Month 25 Day
Date trial data considered complete
2018 Year 09 Month 25 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information The study protocol was approved by the institutional review board of the Gifu Red Cross Hospital (authorization number in 2015: O15111203). We explained the need for intraocular pressure measurements as a surgical monitor of perioperative visual loss prevention, and we obtained written informed consent from each patient at a preoperative meeting.

Management information
Registered date
2017 Year 03 Month 25 Day
Last modified on
2018 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030654

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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