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Completed

NCT Number: NCT01387828

Comparison Between Open and Laparoscopic Splenic Aneurysms Repair

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, BS, 25123, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic splenic aneurysm repair, eventual splenectomy

Procedure

Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparoscopic approach

Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy

Procedure

Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparotomic approach

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Registry information

Official study title

Prospective Randomized Comparison of Open Versus Laparoscopic Management of Splenic Artery Aneurysms. A Ten-Year Study

Important dates

Study start
2001
Primary completion
2011
Study completion
2011
First posted
Jul 6, 2011
Registry last updated
Jul 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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