UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate routine screening for deep vein thrombosis before surgery
Acronym	RSDVT
Scientific Title	A study to evaluate routine screening for deep vein thrombosis before surgery
Scientific Title:Acronym	RSDVT
Region	Japan

Condition
Condition	Completed
Classification by specialty	Surgery in general Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	evaluate screening deep venous thrombosis before surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	occurrence of pulmonary thromboembolism
Key secondary outcomes

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	surgical case
Key exclusion criteria	non-surgical case
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Endoh
Organization	Saku Central Hospital Advanced Care Center
Division name	Thoracic Surgery
Zip code	385-0051
Address	3400-28 Nakagomi, Saku, Nagano
TEL	0267-62-8181
Email	hidend0509@yahoo.co.jp

Public contact
Name of contact person	1st name Hideki Middle name Last name Endoh
Organization	Saku Central Hospital Advanced Care Center
Division name	Thoracic Surgery
Zip code	3850051
Address	3400-28, Nakagomi, Saku, Nagano
TEL	0267-62-8181
Homepage URL
Email	hidend0509@yahoo.co.jp

Sponsor
Institute	Saku Central Hospital
Institute
Department

Funding Source
Organization	Saku Central Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saku central Hospital Advanced Care Center
Address	3400-28 Nakagomi, Saku, Nagano
Tel	0267-62-8181
Email	ctroffice@sakuhp.or.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	2022 Year 01 Month 27 Day

Related information
URL releasing protocol	217 patients were reported to have deep venous thrombosis
Publication of results	Unpublished

Result
URL related to results and publications	217 patients were reported to have deep venous thrombosis
Number of participants that the trial has enrolled	217
Results	217 patients were reported to have deep venous thrombosis. Of the total 217 patients, all were managed using anti-embolism elastic stockings and 111 patients took anticoagulants. No patient was developed with pulmonary thromboembolism.
Results date posted	2022 Year 01 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Not applicable
Participant flow	Not applicable
Adverse events	Not applicable
Outcome measures	Not applicable
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 31 Day
Date of IRB	2017 Year 04 Month 17 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study that observed prognosis after surgery, results of ultra sound screening for deep venous thrombosis before and after surgery, and prevention method which selected by each surgeon without intervention.

Management information
Registered date	2022 Year 01 Month 26 Day
Last modified on	2022 Year 01 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053271