Non Traumatic Splenic RuptureNCT01845662
Non-traumatic Rupture of the Spleen. Can Splenectomy be Applied Selectively?
An observational study of Non Traumatic Splenic Rupture, run by Ziv Hospital at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Non Traumatic Splenic Rupture
- What is being tested?
- Surgical or non-surgical management
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- All patients where review of the medical records indicates non-traumatic rupture of the spleen.
Who cannot join
- Patients with antecedent trauma.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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
- Being tested
- Surgical or non-surgical management
- Keywords
- splenectomy, embolization, observation, blood transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical or non-surgical managementOther
Retrospective surgical (splenectomy) or non-surgical management (embolization or conservative management)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Surgical or non-surgical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Traumatic Splenic RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Amram Hadary, MD, Principal investigator, Ziv Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845662
- Sponsor's protocol ID
- 0020-13-ZIV
- Status last verified
- Apr 2013
- First submitted
- 4 Apr 2013
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-traumatic Rupture of the Spleen. Can Splenectomy be Applied Selectively?
- ClinicalTrials.gov ID
- NCT01845662
- Acronym / sponsor ID
- 0020-13-ZIV
- Conditions
- Non Traumatic Splenic Rupture
- Keywords
- splenectomy, embolization, observation, blood transfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgical or non-surgical management | – | Other: Surgical or non-surgical managementPatients 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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All patients where review of the medical records indicates non-traumatic rupture of the spleen.
Key exclusion criteria (1 listed)
- Patients with antecedent trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical or non-surgical managementRetrospective surgical (splenectomy) or non-surgical management (embolization or conservative management) | Other | surgical or non-surgical management |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amram Hadary, MD principal investigator
Ziv Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Traumatic Splenic Rupture, run by Ziv Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Splenectomy (time frame: 26 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.