Non Traumatic Splenic Rupture Clinical Trial
Official title:
Non-traumatic Rupture of the Spleen. Can Splenectomy be Applied Selectively?
Purpose: Non-traumatic rupture of the spleen should be suspected when patients (especially
young men) present with abdominal pain and a history of acute infectious or
myeloproliferative disorders. Preoperative imaging studies in hemodynamically stable
patients may obviate the need for surgery even in the presence of massive hemoperitoneum.
The purpose of this research is to inform acute management where spontaneous rupture is
suspected in order to avoid surgery where appropriate, rationalise angiographic intervention
and blood transfusion.
Hypothesis: Indentifying the cause of injuries can help target preventative intervention.
Background: Non-traumatic rupture of the spleen is a rare condition. It may occur in the
diseased spleen secondary to a variety of pathologies including malaria and
myeloproliferative disorders. In some cases rupture may occur in an apparently normal
spleen. The incidence, symptoms, causes, therapy and prognosis are poorly defined. The
investigators, therefore, propose an extension of retrospective analysis conducted,
presented and published in 2003 to examine all the cases of non-traumatic splenic rupture
treated at Ziv Medical Centre from the last 26 years to present.
Methods: Analysis of the medical notes of all patients with spontaneous splenic rupture in
the medical archives.
The investigators hope to determine the true incidence of this condition within the local
population, increasingly diverse in origin, travel and the incidence of predisposing
infectious disease; and to devise a practical protocol in their safe diagnosis and
management, especially as non-operative interventions have grown in safety and
effectiveness.
Discussion: Although rare, spontaneous splenic rupture may be fatal if not suspected or
treated inappropriately. Understanding the pitfalls in diagnosis and management better
informs decision making towards improved care of these patients.
| Status | Active, not recruiting |
| Enrollment | 40 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year and older |
| Eligibility |
Inclusion Criteria: - All patients where review of the medical records indicates non-traumatic rupture of the spleen. Exclusion Criteria: - Patients with antecedent trauma. |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Ziv Hospital | Safed | Galilee |
| Lead Sponsor | Collaborator |
|---|---|
| Ziv Hospital |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Splenectomy | This is a retrospective study looking at each case and determining the clinical course. Possible patterns in presentation that determines investigation and management will be observed. Patients with infectious disease or myeloproliferative disease who develop actute abdominal pain routinely have a CT scan and surgical review. If CT shows a bleed and the patient is unstable, the patient must have an intervention to stop the bleeding - usually surgical splenectomy. The outcome is to determine the clinical course of non-traumatic splenic haemorrhage. | 26 years | No |