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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027275
Receipt No. R000029304
Scientific Title Laparoscopic intraperitoneal observational study in patients undergoing open surgery for abdominal aortic and iliac aneurysms
Date of disclosure of the study information 2017/05/09
Last modified on 2017/05/09

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Basic information
Public title Laparoscopic intraperitoneal observational study in patients undergoing open surgery for abdominal aortic and iliac aneurysms
Acronym Laparoscopic observation of abdominal aortic aneurysms
Scientific Title Laparoscopic intraperitoneal observational study in patients undergoing open surgery for abdominal aortic and iliac aneurysms
Scientific Title:Acronym Laparoscopic observation of abdominal aortic aneurysms
Region
Japan

Condition
Condition Abdominal aortic aneurysm and/or iliac artery aneurysm
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is investigate safety and efficacy of laparoscopic intraperitoneal observation in patients undergoing open surgery for abdominal aortic and iliac aneurysms. This is a pilot study to complete laparoscopic aortic surgery in the future.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Efficacy: ability to observe infrarenal aorta and common iliac artery using laparoscopy
It is assessed during surgery.
Key secondary outcomes Safety: to assess damage of the abdominal viscera or other adverse events at the time of discharge

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 In patients who undergo open surgery for abdominal aortic and/or iliac aneurysms, intraperitoneal space, especially infrarenal aorta, is observed using a laparoscope under general anesthesia.
After laparoscopic observation, open surgery for abdominal aortic and/or iliac aneurysms will be done.
Study period is from the day of the surgery to the day of discharge.

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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients falling under all the following conditions are included of this study.
1) Patients who have abdominal aortic aneurysm (the maximum diameter is more than 4.5 cm) and/or iliac aneurysms (the maximum diameter is more than 3.0 cm) and are candidates for open surgery for the disease
2) Patients whose general condition is good and who have no serious comorbidities.
3) Patients who is more than 20 years of age
4) Patients who obtained document consent by his/her free will with sufficient understanding, after receiving sufficient explanation for the participation of this study
5) Patients in a hospital
Key exclusion criteria Patients who fall under any of the following conditions are excluded of this study.

1) Patients who are candidates for endovascular aneurysm repair (EVAR)
2) Ruptured aneurysms
3) Emergency operation
4) Patients who are more than 80 years of age
5) Patients who have a history of myocardial infarction, unstable angina, serious hepatic disease (AST (GOT) > 100 U and/or ALT (GTP) > 100 U), serious kidney disease (serum creatinine > 2.0 mg/dL), or serious pulmonary disease (FEV1 < 1000 ml or FEV1% < 70%)
6) Female patients who are pregnant or have the potential to become pregnant
7) Lactating female patients
8) Patients who are judged as inappropriate for research by research responsibilities (sharing) doctors
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TOSHIFUMI KUDO
Organization Tokyo Medical and Dental University
Division name Vascular Surgery
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5255
Email t-kudo.srg1@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name TOSHIFUMI KUDO
Organization Tokyo Medical and Dental University
Division name Vascular Surgery
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5255
Homepage URL
Email t-kudo.srg1@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 05 Month 09 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 Preinitiation
Date of protocol fixation
2017 Year 05 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 09 Day
Last modified on
2017 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029304

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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