Non-traumatic Rupture of the Spleen. Can Splenectomy be Applied Selectively?

NCT ID: NCT01845662

Last Updated: 2013-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-04-30

Brief 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.

Detailed 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).

Conditions

Non Traumatic Splenic Rupture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

surgical or non-surgical management

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

Intervention Type: OTHER

Retrospective surgical (splenectomy) or non-surgical management (embolization or conservative management)

Interventions

Surgical or non-surgical management

Retrospective surgical (splenectomy) or non-surgical management (embolization or conservative management)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All patients where review of the medical records indicates non-traumatic rupture of the spleen.

Exclusion Criteria

• Patients with antecedent trauma.

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziv Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amram Hadary, MD

Role: PRINCIPAL_INVESTIGATOR

Ziv Hospital

Locations

Ziv Hospital

Safed, Galilee, Israel

Countries

Israel

Other Identifiers

0020-13-ZIV

Identifier Type: -

Identifier Source: org_study_id