UMIN-CTR Clinical Trial

Basic information
Public title	Vascular endothelial disorders and surgical site infection (abdominal surgery)
Acronym	Vascular endothelial disorders and surgical site infection (abdominal surgery)
Scientific Title	Vascular endothelial disorders and surgical site infection (abdominal surgery)
Scientific Title:Acronym	Vascular endothelial disorders and surgical site infection (abdominal surgery)
Region	Japan

Condition
Condition	abdominal surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Monitoring tcpO2 in perioerative period
Basic objectives2	Others
Basic objectives -Others	Measuring endothelial microparticles in perioerative period
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	tcpO2 in perioperative period
Key secondary outcomes	endothelial microparticles in perioperative period

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	Male and Female
Key inclusion criteria	Patients who were over twenty years of age, scheduled to undergo an open surgery with ASA-PS classification of 1 to 3
Key exclusion criteria	Patients with respiratory failure (PaO2 / FIO2<200), under mechanical ventilation, with dermatosis, under immunosuppressive condition, during sepsis, underwent emergency operation and previously participated in this study
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takanori Middle name Last name Aihara
Organization	Tohoku University Hospital
Division name	Anesthesiology
Zip code	9808574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL	022-717-7321
Email	taka.vxiv@gmail.com

Public contact
Name of contact person	1st name Takanori Middle name Last name Aihara
Organization	Tohoku University Hospital
Division name	Anesthesiology
Zip code	9808574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL	022-717-7321
Homepage URL
Email	taka.vxiv@gmail.com

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
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	MHLW Certified Clinical Research Review Board, Tohoku University
Address	2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan
Tel	022-718-0461
Email	office@nrs.hosp.tohoku.ac.jp

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	2020 Year 10 Month 08 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	120
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	No longer recruiting
Date of protocol fixation	2017 Year 01 Month 10 Day
Date of IRB	2018 Year 04 Month 09 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Monitoring tcpO2 in perioperative period and measuring endothelial microparticles. Verifying the relationship between SSI and peripheral circulation.

Management information
Registered date	2020 Year 10 Month 07 Day
Last modified on	2020 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047972