Clinical trial NCT01387828: Comparison Between Open and Laparoscopic Splenic Aneurysms Repair
Official title: Prospective Randomized Comparison of Open Versus Laparoscopic Management of Splenic Artery Aneurysms. A Ten-Year Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Splenic Artery Aneurysm
Keywords: Splenic artery
Aneurysm
laparoscopic
Vascular reconstruction
Splenectomy
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2011-07-06
Enrollment: 29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall postoperative morbidity rate
timeFrame: During and after hospital stay, an expected average of 50 months
Secondary outcomes:
measure: Resumption of oral diet
timeFrame: Partcipants will be followed for the duration of hospital stay, an expected average of one week
measure: Intra-abdominal surgical drain removal time
timeFrame: Partcipants will be followed for the duration of hospital stay, an expected average of one week
measure: Hospital stay length
timeFrame: Partcipants will be followed for the duration of hospital stay, an expected average of one week
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
state: BS
Study officials:
affiliation: Università degli Studi di Brescia
name: Guido AM Tiberio, MD
role: PRINCIPAL_INVESTIGATOR
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