Comparison Between Open and Laparoscopic Splenic Aneurysms Repair

Phase 3

Completed

• Conditions: Splenic Artery Aneurysm
• Interventions: Procedure: Laparoscopic splenic aneurysm repair, eventual splenectomy; Procedure: Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy

• Registration Number: NCT01387828
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2001-01
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-06
• Study First Submitted: 2011-07-01
• Study First Submitted QC: 2011-07-05
• Study First Posted: 2011-07-06
• Last Update Submitted: 2011-07-06
• Last Update Posted: 2011-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopy	Laparoscopic splenic aneurysm repair, eventual splenectomy	Includes all patient underwent intervention with a laparoscopic approach, even if converted to open surgery during intervention
Open surgery	Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy	Includes all the patients underwent intervention with a laparotomic approach; it does not include patient underwent laparoscopic approach and then converted in laparotomy.

Primary Outcome Measures

Name	Time	Method
Overall postoperative morbidity rate	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.

Secondary Outcome Measures

Name	Time	Method
Resumption of oral diet	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	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	Partcipants will be followed for the duration of hospital stay, an expected average of one week	Time between intervention and discharge

Trial Locations

Locations (1)

Azienda Ospedaliera Spedali Civili di Brescia; 🇮🇹 Brescia, BS, Italy