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

April 29, 2013 updated by: Ziv Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Galilee
      • Safed, Galilee, Israel, 13100
        • Ziv Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in Ziv Hospital referred to the surgical department with acute onset abdominal pain or CT findings of splenic rupture without a history of trauma

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with antecedent trauma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Surgical or non-surgical management
Retrospective surgical (splenectomy) or non-surgical management (embolization or conservative management)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Splenectomy
Time Frame: 26 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ziv Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amram Hadary, MD, Ziv Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0020-13-ZIV

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