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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name