Comparison Between Open and Laparoscopic Splenic Aneurysms Repair

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

Detailed Description
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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.

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

Conditions
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Splenic Artery Aneurysm

Intervention / Treatment
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* Procedure: Laparoscopic splenic aneurysm repair, eventual splenectomy
* Procedure: Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopy<br>Includes all patient underwent intervention with a laparoscopic approach, even if converted to open surgery during intervention | Procedure: Laparoscopic splenic aneurysm repair, eventual splenectomy<br>* Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparoscopic approach<br>|
| Active Comparator: Open surgery<br>Includes all the patients underwent intervention with a laparotomic approach; it does not include patient underwent laparoscopic approach and then converted in laparotomy. | Procedure: Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy<br>* Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparotomic approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall postoperative morbidity rate | 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. | During and after hospital stay, an expected average of 50 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resumption of oral diet | Time between the intervention and patient oral intake without problems | Partcipants will be followed for the duration of hospital stay, an expected average of one week | 
| Intra-abdominal surgical drain removal time | Time between intervention and removal of surgical drain | Partcipants will be followed for the duration of hospital stay, an expected average of one week | 
| Hospital stay length | Time between intervention and discharge | Partcipants will be followed for the duration of hospital stay, an expected average of one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Splenic artery, Aneurysm, laparoscopic, Vascular reconstruction, Splenectomy