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.
Non-traumatic rupture of the spleen is a rare condition. It may occur in the diseased spleen
should be suspected when patients (especially young men) present with abdominal pain and a
history of acute infectious or myeloproliferative disorders. Rarely, rupture may occur
within an apparently normal spleen. The incidence, symptoms, causes, therapy and prognosis
are poorly defined. We, therefore, propose an extension of retrospective analysis already
presented in 2003 to examine all the cases of non-traumatic splenic rupture treated at Ziv
Medical Centre over the last 26 years and to rationalise treatment plans taking into
consideration pitfalls and complications in management so that the care and outcome for
these patients is improved.
Methods:
Patients with a diagnosis of non-traumatic splenic rupture will be identified from the
hospital database, their medical records retrieved and analysed to determine their actual
diagnosis and examine their management and outcomes.
Time frame:
The retrospective data over the last 26 years will be analysed over the next year.
Endpoints:
This is a retrospective study. Our records indicate that as non-traumatic splenic rupture is
a rare diagnosis, there are fewer than 50 patients listed with this diagnosis, fewer still,
where examination of the medical records will reveal this to be the actual diagnosis.
Inclusion criteria:
All patients where review of the medical records indicates non-traumatic rupture of the
spleen.
Exclusion criteria:
Patients with antecedent trauma. Statistical analysis: Data will be subjected to statistical
analysis using IBM SPSS and incremental risk calculator software.
Budget: not needed
Ethics:
This study focuses only on the analysis of medical records. Supplementary information from
patients and health care staff will not be collected. There are no interviews or
questionnaires planned and data nor treatment outcomes will be discussed outside the context
of scientific debate (including presentation and publication).
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Observational Model: Cohort, Time Perspective: Retrospective