UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026701 |
|---|---|
| Receipt number | 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 22:27:52 |
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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
| Obstetrics 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
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
m-yoji@qc5.so-net.ne.jp
Sponsor or person
Institute
Gifu Red Cross Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030654
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
