UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008345
Receipt number R000007421
Scientific Title National Hospital Organization Network Study for prospective registry of aoritc aneurysm repair
Date of disclosure of the study information 2012/07/05
Last modified on 2021/07/27 11:38:33

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Basic information

Public title

National Hospital Organization Network Study for prospective registry of aoritc aneurysm repair

Acronym

NHONW study for prospective registration of aortic aneurysm repair

Scientific Title

National Hospital Organization Network Study for prospective registry of aoritc aneurysm repair

Scientific Title:Acronym

NHONW study for prospective registration of aortic aneurysm repair

Region

Japan


Condition

Condition

abdominal aortic aneurysm

Classification by specialty

Vascular surgery Cardiovascular surgery Operative medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The chnge of surgical outcomes regarding repair of abdominal aortic aneurysm in introduction of endovascular repar technology into Japan.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

aneurysm related mortality

Key secondary outcomes

enlargement of aneurysmal diameter


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who had treatment for abdominal aortic and/or iliac artery aneurysm with the following criteria: maximum external diameter more than 5cm or 4-5cm with rapid enlargement, or saccular morphology which carried high risk of rupture. In some patients, they were treated for main location of common iliac artery aneurysm if their maximum size was more than twice the normal diameter.

Key exclusion criteria

Patients who require concomittant repair of thoracic and/or thoracoabdominal aneurysm repair or who require reconstruction of abdominal branches.

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name Toshihiro
Middle name
Last name Onohara

Organization

National Hospital Organization, Kyusyu Medical Center

Division name

Department of vascular Surgery

Zip code

810-8563

Address

1-8-1, Jigyouhama, Cyuou-ku, Fukuoka-shi

TEL

+81-092-852-0700

Email

nhanda111@gmail.com


Public contact

Name of contact person

1st name Nobuhiro
Middle name
Last name Handa

Organization

Nagara Medical Center

Division name

Department of Cardiovascular Surgery

Zip code

502-8558

Address

1300-7, Nagara, Gifu, Japan

TEL

+81-58-232-7755

Homepage URL


Email

nhanda11@nagara-lan.hosp.go.jp


Sponsor or person

Institute

National Hopital Organization Network Group for abdominal aortic aneurysm

Institute

Department

Personal name



Funding Source

Organization

National Hopital Organization

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Hospital Organization, Kyusyu Medical Center

Address

1-8-1, JIgyouhama, cyuou-ku, Fukkuoka-shi

Tel

+81-92-852-0700

Email

nhanda111@gmail.com


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

国立病院機構北海道医療センター、金沢医療センター、長良医療センター、大阪医療センター、大阪南医療センター、岡山医療センター、岩国医療センター、呉医療センター、東広島医療センター、九州医療センター、熊本医療センター、鹿児島医療センター、浜田医療センター、


Other administrative information

Date of disclosure of the study information

2012 Year 07 Month 05 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Though significant differences in patient characteristics between EVAR and open surgical group were noted, early results were satisfactory in both groups.
Proportion of EVAR in AAA repair increased from 0% into 48.8% over 8 years. Surgical death was comaprable after patient charaqcteristics were adjusted.Overall, indication of AAA repair was extended without increasing the hospital mortality.
Late sac enlargement of AAA after EVAR was assessed, which disclosed that about 20% of cases showed sac enlargement at 5 years.
Late intervention was also assessed, which disclosed that late intervention was required in about 15% of patients after EVAR at 5 years. It include about 6% of surgical conversion such as graft replacement, sacotomy, femoro-femoral bypass or thrombectomy for graft occlusion.

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

2009 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 05 Month 01 Day

Last follow-up date

2024 Year 12 Month 01 Day

Date of closure to data entry

2024 Year 12 Month 01 Day

Date trial data considered complete

2024 Year 12 Month 01 Day

Date analysis concluded

2025 Year 12 Month 01 Day


Other

Other related information

The primary outcome measure was surgical mortality. It is defined as either any cause of death within 30days after operation or in-hospital mortality without discharge at any time. The secondary outcome measures included early morbidities, and intermediate term results. Details of treatments were described such as procedure time, volume of blood transfusion, and process of recovery including hours of respiratory management, length of intensive care unit stay (ICU stay), procedure failure requiring additional procedure during same hospitalization, and re-admission within 30days.


Management information

Registered date

2012 Year 07 Month 04 Day

Last modified on

2021 Year 07 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007421


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name