Azienda Ospedaliera Spedali Civili di Brescia
Brescia, BS, 25123, Italy
NCT Number: NCT01387828
The purpose of this study is compare two different surgical treatments of splenic artery aneurysms: open and laparoscopic approach.
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Interventional
Phase 3
Brescia, BS, 25123, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparoscopic approach
Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparotomic approach
Time frame: 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.
Time frame: 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
Time frame: Partcipants will be followed for the duration of hospital stay, an expected average of one week
Time between intervention and removal of surgical drain
Time frame: Partcipants will be followed for the duration of hospital stay, an expected average of one week
Time between intervention and discharge
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Other
Prospective Randomized Comparison of Open Versus Laparoscopic Management of Splenic Artery Aneurysms. A Ten-Year Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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