UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027275 |
|---|---|
| Receipt number | 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 | 2024/04/01 15:54:24 |
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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 | TOSHIFUMI |
| Middle name | |
| Last name | KUDO |
Organization
Tokyo Medical and Dental University
Division name
Vascular Surgery
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5255
t-kudo.srg1@tmd.ac.jp
Public contact
Name of contact person
| 1st name | TOSHIFUMI |
| Middle name | |
| Last name | KUDO |
Organization
Tokyo Medical and Dental University
Division name
Vascular Surgery
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5255
Homepage URL
t-kudo.srg1@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
IRB of Tokyo Medical and Dental University
Address
1-5-45, Yusmiya, Bunkyo-ku, Tokyo
Tel
03-5803-5226
syomu1.adm@tmd.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
| 2017 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
https://www.tmd.ac.jp/srg/synnryou/vascularsrg/134_5ab8397790df6/
Publication of results
Published
Result
URL related to results and publications
https://www.tmd.ac.jp/srg/synnryou/vascularsrg/134_5ab8397790df6/
Number of participants that the trial has enrolled
5
Results
Protocol was completed in 5 patients.
Results date posted
| 2024 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age: 61-68
All male
Participant flow
Protocol was completed in 5 patients.
Adverse events
none
Outcome measures
Protocol was completed in 5 patients.
No adverse event was found in all cases.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 09 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029304
