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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021671
Receipt No. R000023679
Scientific Title Prospective cohort study for functional outcomes after surgery.
Date of disclosure of the study information 2016/04/01
Last modified on 2019/10/01

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Basic information
Public title Prospective cohort study for functional outcomes after surgery.
Acronym Functional outcomes after surgery trial (FOAS trial)
Scientific Title Prospective cohort study for functional outcomes after surgery.
Scientific Title:Acronym Functional outcomes after surgery trial (FOAS trial)
Region
Japan

Condition
Condition Disease undergoing surgery in anesthesiology management
Classification by specialty
Surgery in general Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 the incidence of postoperative functional disability(POFD).
Basic objectives2 Others
Basic objectives -Others risk factor of POFD
clinical diagnosis predictor
the incidence of postoperative complication
quality of death
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes WHODAS2.0
Key secondary outcomes SF8, TMIG Index, Good Death Inventory (GDI), life and death, re-operation, re-hospitalization, cerebrovascular disease, myocardial infarction, artificial respiration, entry into the intensive care unit, nerve damage, hoarseness, cardiac arrest, sepsis, pulmonary thromboembolism disease, satisfaction, extubation during storage, intraoperative awakening, hoarseness, tooth damage, sore throat, nausea and vomiting, pain at the time of examination, nerve damage, dural puncture after headache, itching

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
55 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing surgery under the management by anesthegiologists
Patients who can answer the questionnaire
Key exclusion criteria Patients who can't answer to TMIG Index, SF 8, WHODAS2.
Patients who undergo re-operation during hospitalization.
Patients who can't well understand Japanese
Target sample size 4500

Research contact person
Name of lead principal investigator
1st name Masahiko
Middle name
Last name Kawaguchi
Organization Nara Medical University
Division name Anesthesiology
Zip code 6348523
Address 840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL 0744-22-3051
Email drjkawa@gmail.com

Public contact
Name of contact person
1st name Mitsuru
Middle name
Last name Ida
Organization Nara Medical University
Division name Anesthesiology
Zip code 6348523
Address 840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL 0744-22-3051
Homepage URL
Email nwnh0131@yahoo.co.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Nara prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nara Medical University
Address Shijo-machi 840
Tel 0744298902
Email nwnh0131@yahoo.co.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 奈良県立医科大学

Other administrative information
Date of disclosure of the study information
2016 Year 04 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 4500
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
2015 Year 12 Month 31 Day
Date of IRB
2015 Year 10 Month 20 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information cohort
Everyone who meet the selection criteria in patients who underwent surgery at our facility in April 2016-March 2018

Management information
Registered date
2016 Year 03 Month 29 Day
Last modified on
2019 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023679

Research Plan
Registered date File name
2016/05/06 倫理委員会 前.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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