UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012207 |
|---|---|
| Receipt number | R000014208 |
| Scientific Title | Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure during laparoscopic gynecological surgery |
| Date of disclosure of the study information | 2013/11/04 |
| Last modified on | 2013/11/11 10:32:48 |
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Basic information
Public title
Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure during laparoscopic gynecological surgery
Acronym
Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure during laparoscopic gynecological surgery
Scientific Title
Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure during laparoscopic gynecological surgery
Scientific Title:Acronym
Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure during laparoscopic gynecological surgery
Region
| Japan |
Condition
Condition
benign gynecologic tumors
malignant gynecologic tumors
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the intracranial pressure by ultrasonography of optic nerve sheath diameter during laparoscopic gynecological surgery.
To evaluate that laparoscopic gynecological surgery elevates the intracranial pressure
Basic objectives2
Others
Basic objectives -Others
detection of physiological change
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
increase of optic nerve sheath diameter from baseline
Key secondary outcomes
perioperative neurological complications
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.>=20 years old Japanese female
2.Performance status 1 or 2
3.elective laparoscopic gynecological surgery
Key exclusion criteria
1.past history of intracranial hypertension
2.Patients were deemed inappropriate by research investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Yamaguchi |
Organization
Yokohama City University
Division name
school of medicine, department of anesthesiology and critical care medicine
Zip code
Address
3-9 Fukura, Kanazawa-ku, Yokohama, 236 JAPAN
TEL
0457872511
yoshikaz@rd6.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Yamaguchi |
Organization
Yokohama City University
Division name
Department of aneshtesiology and critical care medicine
Zip code
Address
3-9 Fukura, Kanazawa-ku, Yokohama, 236 JAPAN
TEL
0457872511
Homepage URL
yoshikaz@rd6.so-net.ne.jp
Sponsor or person
Institute
Yokohama city university school of medicine, department of anesthesiology and critical care medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yamato Municipal Hospital
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
横浜市立大学附属病院（神奈川県）, Yokohama City University Hospital
大和市立病院（神奈川県）, Yamato Municipal Hospital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Ultrasonography of optic nerve sheath diameter is performed at the following point.
After anesthetic induction
after head down position and aeroperitoneum
and every 60 minutes.
Management information
Registered date
| 2013 | Year | 11 | Month | 04 | Day |
Last modified on
| 2013 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014208
