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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012207
Receipt No. 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

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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
Obsterics 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
Email 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
Email yoshikaz@rd6.so-net.ne.jp

Sponsor
Institute Yokohama city university school of medicine, department of anesthesiology and critical care medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014208

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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