Comparison Between Open and Laparoscopic Splenic Aneurysms Repair

July 6, 2011 updated by: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BS
      • Brescia, BS, Italy, 25123
        • Azienda Ospedaliera Spedali Civili di Brescia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During and after hospital stay, an expected average of 50 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Partcipants will be followed for the duration of hospital stay, an expected average of one week
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
Partcipants will be followed for the duration of hospital stay, an expected average of one week
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
Partcipants will be followed for the duration of hospital stay, an expected average of one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Investigators

  • Principal Investigator: Guido AM Tiberio, MD, Università degli Studi di Brescia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

July 1, 2011

First Submitted That Met QC Criteria

July 5, 2011

First Posted (Estimate)

July 6, 2011

Study Record Updates

Last Update Posted (Estimate)

July 7, 2011

Last Update Submitted That Met QC Criteria

July 6, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOB 01-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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