Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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


Condition Intervention Phase
Splenic Artery Aneurysm
Procedure: Laparoscopic splenic aneurysm repair, eventual splenectomy
Procedure: Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Comparison of Open Versus Laparoscopic Management of Splenic Artery Aneurysms. A Ten-Year Study

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Spedali Civili di Brescia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 29
Study Start Date: January 2001
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387828

Locations
Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, BS, Italy, 25123
Sponsors and Collaborators
Azienda Ospedaliera Spedali Civili di Brescia
Investigators
Principal Investigator: Guido AM Tiberio, MD Università degli Studi di Brescia
  More Information

Publications:

Responsible Party: Guido A M Tiberio, MD, AOBrescia
ClinicalTrials.gov Identifier: NCT01387828     History of Changes
Other Study ID Numbers: AOB 01-11
Study First Received: July 1, 2011
Last Updated: July 6, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera Spedali Civili di Brescia:
Splenic artery
Aneurysm
laparoscopic
Vascular reconstruction
Splenectomy

Additional relevant MeSH terms:
Aneurysm
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014