Splenic Artery Aneurysm
Conditions
Keywords
Splenic artery, Aneurysm, laparoscopic, Vascular reconstruction, Splenectomy
Brief 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.
Interventions
PROCEDURELaparoscopic splenic aneurysm repair, eventual splenectomy
Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparoscopic approach
PROCEDURELaparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy
Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparotomic approach
Sponsors
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall postoperative morbidity rate | During and after hospital stay, an expected average of 50 months | According to Dindo-Clavien classification of postoperative complication, we collect in a prospective way and classify all the possible complication by direct clinical evaluation and additional blood sample, imaging or endoscopy if required. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resumption of oral diet | Partcipants will be followed for the duration of hospital stay, an expected average of one week | Time between the intervention and patient oral intake without problems |
| Intra-abdominal surgical drain removal time | Partcipants will be followed for the duration of hospital stay, an expected average of one week | Time between intervention and removal of surgical drain |
| Hospital stay length | Partcipants will be followed for the duration of hospital stay, an expected average of one week | Time between intervention and discharge |
Countries
Italy
Outcome results
None listed