A Phase 3 interventional study of Laparoscopic splenic aneurysm repair, eventual splenectomy and Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy in Splenic Artery Aneurysm, sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2011-07-07.
Sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Phase 3, Interventional, and Treatment
The purpose of this study is compare two different surgical treatments of splenic artery aneurysms: open and laparoscopic approach.
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.
956 studies on the registry are indexed under Aneurysm; 171 are open to participants now.
This study's enrollment of 29 is below the median of 72 across 460 interventional studies indexed under Aneurysm.
Browse Aneurysm studies →Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Includes all patient underwent intervention with a laparoscopic approach, even if converted to open surgery during intervention
Procedure: Laparoscopic splenic aneurysm repair, eventual splenectomy
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
Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparoscopic approach
Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparotomic approach
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.
Time frame: During and after hospital stay, an expected average of 50 months
Resumption of oral diet
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
Intra-abdominal surgical drain removal time
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
Hospital stay length
Time between intervention and discharge
Time frame: Partcipants will be followed for the duration of hospital stay, an expected average of one week
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia