Splenic Artery Aneurysm Clinical Trial
Official title:
Prospective Randomized Comparison of Open Versus Laparoscopic Management of Splenic Artery Aneurysms. A Ten-Year Study
The purpose of this study is compare two different surgical treatments of splenic artery aneurysms: open and laparoscopic approach.
Laparoscopy has not spread into vascular surgery as it has in other surgical branches and
still remains in the hands of a minority of surgeons. Splenic artery aneurysm (SAA) is an
exception to the rule: an easy-to-reach position and relatively safe control favour the
progressive diffusion of laparoscopic techniques.
An increasing number of cases is managed by minimally invasive surgery originating a number
of case reports and small series published in recent literature. These papers are unanimous
in signalling the feasibility, safety and effectiveness of laparoscopic technique as well as
its appreciation by patients -often young females- who harbour the disease. However,
perplexities still remain concerning the real potential of laparoscopy in this specific
field, in particular considering the spectrum of technical solutions to be performed, the
splenectomy rate and the feasibility and results of reconstructive surgery.
The low incidence of the disease justifies the low number of published laparoscopic series
enrolling an adequate number of patients and, in particular, the absence of papers comparing
open and laparoscopic techniques.
This study reports the first prospective randomized comparison of the different surgical
techniques.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment