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Comparison Between Open and Laparoscopic Splenic Aneurysms Repair

This study has been completed.
Sponsor:
Information provided by:
Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier:
NCT01387828
First received: July 1, 2011
Last updated: July 6, 2011
Last verified: June 2011

July 1, 2011
July 6, 2011
January 2001
April 2011   (final data collection date for primary outcome measure)
Overall postoperative morbidity rate [ Time Frame: During and after hospital stay, an expected average of 50 months ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01387828 on ClinicalTrials.gov Archive Site
  • Resumption of oral diet [ Time Frame: Partcipants will be followed for the duration of hospital stay, an expected average of one week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time between intervention and discharge
Same as current
Not Provided
Not Provided
 
Comparison Between Open and Laparoscopic Splenic Aneurysms Repair
Prospective Randomized Comparison of Open Versus Laparoscopic Management of Splenic Artery Aneurysms. A Ten-Year Study

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Splenic Artery Aneurysm
  • Procedure: Laparoscopic splenic aneurysm repair, eventual splenectomy
    Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparoscopic approach
  • Procedure: Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy
    Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparotomic approach
  • Active Comparator: Laparoscopy
    Includes all patient underwent intervention with a laparoscopic approach, even if converted to open surgery during intervention
    Intervention: Procedure: Laparoscopic splenic aneurysm repair, eventual splenectomy
  • 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.
    Intervention: Procedure: Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01387828
AOB 01-11
Yes
Guido A M Tiberio, MD, AOBrescia
Azienda Ospedaliera Spedali Civili di Brescia
Not Provided
Principal Investigator: Guido AM Tiberio, MD Università degli Studi di Brescia
Azienda Ospedaliera Spedali Civili di Brescia
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP