aparoscopic intraperitoneal observational study in patients undergoing open surgery for abdominal aortic and iliac aneurysms

Phase 1

• Conditions: Abdominal aortic aneurysm and/or iliac artery aneurysm

• Registration Number: JPRN-UMIN000027275
• Lead Sponsor: Tokyo Medical and Dental University

Brief Summary

Protocol was completed in 5 patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-09
• Study Completion: 2020-03-31
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy: ability to observe infrarenal aorta and common iliac artery using laparoscopy It is assessed during surgery.

Secondary Outcome Measures

Name	Time	Method
Safety: to assess damage of the abdominal viscera or other adverse events at the time of discharge