NCT01387828

Comparison Between Open and Laparoscopic Splenic Aneurysms Repair

Prospective Randomized Comparison of Open Versus Laparoscopic Management of Splenic Artery Aneurysms. A Ten-Year Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is compare two different surgical treatments of splenic artery aneurysms: open and laparoscopic approach.

Detailed description

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.

Conditions

• Splenic Artery Aneurysm

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic splenic aneurysm repair, eventual splenectomy	Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparoscopic approach
PROCEDURE	Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy	Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparotomic approach

Timeline

• Start date: 2001-01-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2011-07-06
• Last updated: 2011-07-07

Locations

1 site across 1 country: Italy