Comparison Between Open and Laparoscopic Splenic Aneurysms Repair

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status and phase: Completed; Phase 3

Conditions: Splenic Artery Aneurysm

Treatments: Procedure: Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy; Procedure: Laparoscopic splenic aneurysm repair, eventual splenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01387828

AOB 01-11

Details and patient eligibility

About

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

Full 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.

Enrollment: 29 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Splenic artery aneurysm with diameter greater than 2 cm
• Splenic artery aneurysm with diameter smaller than 2 cm if risk factors for rupture are associated (child bearing age, pregnancy, blister or saccular shape, increasing diameter)

Exclusion criteria

• Complex aneurysm involving the celiac trunk
• American Society of Anesthesiologists (ASA) Score > 3

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Laparoscopy

Active Comparator group

Description:

Includes all patient underwent intervention with a laparoscopic approach, even if converted to open surgery during intervention

Treatment:

Procedure: Laparoscopic splenic aneurysm repair, eventual splenectomy

Open surgery

Active Comparator group

Description:

Includes all the patients underwent intervention with a laparotomic approach; it does not include patient underwent laparoscopic approach and then converted in laparotomy.

Treatment:

Procedure: Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy