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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041395
Receipt No. R000047254
Scientific Title Prospective study of walking ability after aortoiliac aneurysm repair
Date of disclosure of the study information 2020/08/12
Last modified on 2021/08/17

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Basic information
Public title Prospective study of walking ability after aortoiliac aneurysm repair
Acronym Prospective study of walking ability after aortoiliac aneurysm repair
Scientific Title Prospective study of walking ability after aortoiliac aneurysm repair
Scientific Title:Acronym Prospective study of walking ability after aortoiliac aneurysm repair
Region
Japan

Condition
Condition Aortoiliac aneurysm
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to elucidate whether aortoiliac aneurysm repair affects postoperative walking ability.
Basic objectives2 Others
Basic objectives -Others Postoperative walking ability can be affected by open surgical aneurysm repair or embolization of hypogastric artery. This prospective study elucidate changes of walking ability in objective and subjective manners.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of postoperative claudication and disturbance in gait
Key secondary outcomes 1) Postoperative pain free walking distance and maximum walking distance
2) Postoperative change of Spatiotemporal and kinetic parameters
3) Postoperative evaluation of walking impairment questionnaire (WIQ)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Patients undergo walk test, preoperatively, 1 week postoperatively, and thereafter 1, 3, 6, 12, 24 months postoperatively.
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. Patients scheduled to aortoiliac aneurysm repair.
2. Capability of moderate-to-vigorous daily physical activity (defined as three metabolic equivalents [METs] or more).
Key exclusion criteria 1. Vascular or neurogenic claudication.
2. Lack of independence for activities of daily living, lack of capability of moderate-to-vigorous daily physical activity (defined as three metabolic equivalents [METs] or more).
3. Undergoing treatment that may affect activity level (cardiac/cardiovascular surgery, neurosurgery/cerebrovascular surgery, laparotomy, trunk/lower-limb musculoskeletal surgery, or revascularization of lower extremities) during the study period.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Daijirou
Middle name
Last name Akamatsu
Organization Tohoku University Hospital
Division name Department of Surgery
Zip code 980-8574
Address Seiryo-cho 1-1,Sendai-shi,Miyagi.
TEL 022-717-7214
Email daijirou@surg.med.tohoku.ac.jp

Public contact
Name of contact person
1st name Daijirou
Middle name
Last name Akamatsu
Organization Tohoku University Hospital
Division name Department of Surgery
Zip code 980-8574
Address Seiryo-cho 1-1,Sendai-shi,Miyagi.
TEL 022-717-7214
Homepage URL
Email daijirou@surg.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and
Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Clinical Research Innovation and Education Center Tohoku University Hospital
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel 022-717-7122
Email office@crieto.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 08 Month 12 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 Enrolling by invitation
Date of protocol fixation
2020 Year 09 Month 20 Day
Date of IRB
2020 Year 10 Month 01 Day
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2027 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 12 Day
Last modified on
2021 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047254

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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