UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041395 |
|---|---|
| Receipt number | 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 | 2025/02/14 09:53:10 |
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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
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
daijirou@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
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
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
25
Results
there was no significant difference in 6 minute walk distance and WIQ score between patients with preserved IIA and with embolized IIA.
Results date posted
| 2025 | Year | 02 | Month | 14 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
because of delay of data analysis
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
The present study is continued smoothly.
Management information
Registered date
| 2020 | Year | 08 | Month | 12 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047254
