Overview

This trial is active, not recruiting.

Condition non traumatic splenic rupture
Treatment surgical or non-surgical management
Sponsor Ziv Hospital
Start date April 2013
End date April 2014
Trial size 40 participants
Trial identifier NCT01845662, 0020-13-ZIV

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Patients with non traumatic cause of splenic rupture such as infectious disease (e.g. malaria)and myeloproliferative that have been treated conservatively in one group and operatively in another group.
surgical or non-surgical management
Retrospective surgical (splenectomy) or non-surgical management (embolization or conservative management)

Primary Outcomes

Measure
Splenectomy
time frame: 26 years

Eligibility Criteria

Male or female participants at least 1 year old.

Inclusion Criteria: - All patients where review of the medical records indicates non-traumatic rupture of the spleen. Exclusion Criteria: - Patients with antecedent trauma.

Additional Information

Official title Non-traumatic Rupture of the Spleen. Can Splenectomy be Applied Selectively?
Principal investigator Amram Hadary, MD
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Ziv Hospital.