Comparison Between Open and Laparoscopic Splenic Aneurysms Repair
|ClinicalTrials.gov Identifier: NCT01387828|
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : July 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|Splenic Artery Aneurysm||Procedure: Laparoscopic splenic aneurysm repair, eventual splenectomy Procedure: Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Comparison of Open Versus Laparoscopic Management of Splenic Artery Aneurysms. A Ten-Year Study|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Active Comparator: Laparoscopy
Includes all patient underwent intervention with a laparoscopic approach, even if converted to open surgery during intervention
Procedure: Laparoscopic splenic aneurysm repair, eventual splenectomy
Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparoscopic approach
Active Comparator: Open surgery
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 laparotomic approach
- Overall postoperative morbidity rate [ 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.
- Resumption of oral diet [ 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
- Intra-abdominal surgical drain removal time [ 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
- Hospital stay length [ Time Frame: Partcipants will be followed for the duration of hospital stay, an expected average of one week ]Time between intervention and discharge
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387828
|Azienda Ospedaliera Spedali Civili di Brescia|
|Brescia, BS, Italy, 25123|
|Principal Investigator:||Guido AM Tiberio, MD||Università degli Studi di Brescia|