UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024189 |
|---|---|
| Receipt number | R000024911 |
| Scientific Title | Ultrasound measurement of optic nerve sheath diameter for intracranial pressure monitoring during laparoscopic colorectomy |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2017/10/16 13:20:12 |
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Basic information
Public title
Ultrasound measurement of optic nerve sheath diameter for intracranial pressure monitoring during laparoscopic colorectomy
Acronym
Ultrasound measurement of optic nerve sheath diameter for intracranial pressure monitoring during laparoscopic colorectomy
Scientific Title
Ultrasound measurement of optic nerve sheath diameter for intracranial pressure monitoring during laparoscopic colorectomy
Scientific Title:Acronym
Ultrasound measurement of optic nerve sheath diameter for intracranial pressure monitoring during laparoscopic colorectomy
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery | Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We measured optic nerve sheath diameter as the predicttive factor a of the intracranial pressure during the operation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wemeasured optic nerve sheath diameter asa the predictive factor of the intracranial peressure during the operation
Key secondary outcomes
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
measure the optic nerve sheath diameter by sonography
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
Male and Female
Key inclusion criteria
1) The patient who undergoes laparoscopi operation with head down position under general anesthesia in Osaka national hospital
2) At the time of the anesthesia written consent acquisition, age is a patient 20 years or older.
3) It is a patient of class 1-3 by American Society of Anesthesiologists preoperation evaluation classification.
4) Sex: No object
5) The weight: No object
6) Having smoking or not: No object
7) A taste career: No object
8) A concomitant drug: No object
Key exclusion criteria
The applicable patient intends for even one following houses and excludes it.
1) It is a patient of class 4-6 by American Society of Anesthesiologists preoperation evaluation classification.
2) In addition, the patient who judged that the medical attendant of the final examination was inappropriate.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mari Sunohara |
Organization
Osaka National Hospital
Division name
division of anesthesiology
Zip code
Address
2-1-14 Hoenzaka tyuouku oosaka city
TEL
06-6942-1331
sunohara@onh.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mari Sunohara |
Organization
Osaka National Hospital
Division name
division of anesthesiology
Zip code
Address
2-1-14 Hoenzaka Cyuou-ku Oosaka city
TEL
06-6942-1331
Homepage URL
sunohara@onh.go.jp
Sponsor or person
Institute
Osaka National Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka National Hospital
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 27 | Day |
Last modified on
| 2017 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024911
