Traumatic Splenic Injury and Management
"Quality of Life and Clinical Outcomes of Treatment for Splenic Injury after Trauma"
Retrospective study

Morbidity and mortality are the most commonly used outcome parameters in the
literature on trauma care. However, most patients will survive their trauma and
depending on the severity of the trauma, they will be limited in daily life,
both physically and mentally. Multiple studies has shown psychological
complaints and decreased quality of life (QOL) in severely injured patients.
[1-3] These factors have a major social and economic impact because it often
involves young patients, who frequently become unsuitable to return to work, to
reintegrate back into society or to retrieve their previous activity level.
Despite that QOL is an important factor, it is still not widely used in trauma
care studies.

In splenic injury after blunt abdominal trauma much is known about morbidity
and mortality, but still very little in terms of QOL. The spleen is one of the
most frequently injured organ after blunt abdominal trauma. [4] Internal
bleeding caused by abdominal organ injury is one of the main causes of death
after trauma, and a missed splenic rupture is the most common cause of
preventable death in trauma patients. [5,6]
Presently, the standard of care in hemodynamically stable patients is
nonoperative management (NOM) involving close observation of the patient, with
success rates up to 90%. [4] Angiography and splenic artery embolization (SAE)
can be used as a supplement to NOM when necessary. The success rate of SAE
ranges from 73% to 100% with an overall success rate of NOM combined with SAE
from 86% to 100% (most studies reporting success rates greater than 90%). [7]
There is still much unknown about splenic function after SAE, but there seems
to be a link between splenic volume and immunologic status of the patient.
Preservation of splenic function is one of the biggest advantages of NOM and
SAE. Avoiding post-splenectomy complications such as sepsis and thrombocytosis
and potentially preventing a lifetime risk of invasive infections. [8,9] In
other words, avoiding factors with major impact on quality of life.
In all three therapies (NOM, SAE and surgery) minor and major complications may
occur. Patients treated with SAE have a risk of developing splenic infarction,
abscesses or cysts, with distal embolization having a significantly higher
association with major complications compared to proximal embolization. [10]
A recent study suggests that there are prognostic factors for failure of NOM in
the treatment of adults with blunt splenic injury. Strong evidence exists for:
age of 40 years or above, Injury Severity Score (ISS) of 25 or greater and
American Association for the Surgery of Trauma (AAST) splenic injury grade of 3
or greater. [11] Failure of therapy leads to more interventions, longer
hospital stay and higher mortality; resulting in decreased QOL and increased
costs.

There is a growing demand for a (national) guideline or protocol for clinical
decision-making in traumatic splenic injuries. For that reason it is important
to determine the optimal selection criteria for the appropriate management
strategy. This can only be achieved by looking at the entire process
surrounding a trauma patient.

The first aim of this project is to determine/compare the quality of life (QOL)
and clinical outcome of patients after therapy (NOM, SAE, splenectomy) for
traumatic splenic injury. First, this will be done with a retrospective group
of patients and the results hereof will be extracted into the prospective part
of the study.
The second aim is (I) to examine therapy-related complications, (II) to
establish the necessity of additional therapies, (III) the assessment of
splenic function related to splenic morphology (MR imaging) after treatment,
and (IV) to find the prognostic factors for failure of non-operative management
(NOM) in patients with splenic injuries.

Finally, with the acquired data from this study a patient-oriented protocol
will be provided for the management of traumatic splenic injury.

The primary objective of this project is to demonstrate the equivalence of
treatment of traumatic splenic injury with splenic artery embolization (SAE)
compared to splenectomy and non-operative management (NOM) in terms of quality
of life measured by WHOQOL-Bref and quality of life short-form-12 questionnaire.

Furthermore, the three treatments will be compared in terms of clinical
outcomes, recovery related outcomes, quality of life outcomes and cost
outcomes. Also imaging outcomes will be investigated in the SAE group, thereby
identifying morphological (versus immunological) aspects of the spleen after
endovascular treatment.

Finally, with the acquired data from this study a patient-oriented protocol
will be provided for the management of traumatic splenic injury.

Specific questions:
1. Is SAE superior to splenectomy in terms of quality of life outcome after
treatment?
2. How do NOM, SAE and splenectomy compare in terms of complications during
treatment, need for re-intervention and hospital stay (days)?
3. How does SAE affect imaging outcomes (splenic morpholical characteristics
such as volume, necrosis, splenosis, calcifications or chronic infarction
morphology) 1 month and 1 year after embolization?
4. Can we design a patient-oriented protocol for the treatment of traumatic
splenic injury?
5. Is there a difference between proximal versus distal SAE?
(immunologic/imaging)
6. What are the prognostic factors for failure of NOM?

A combination of a retrospective and a prospective multicentre cohort study
will be conducted comparing non-operative management (NOM), splenic artery
embolization (SAE) and splenectomy in patients with splenic injury after blunt
abdominal trauma. This protocol is designed for the retrospective part of the
study. This is supplemented with a systematic review of the literature that
will be written according to the PRISMA criteria [13].
The literature search will consist of a staged process in order to retrieve all
relevant articles. First, an extensive literature search will be done using
PubMed, Cochrane, and PsycINFO and the publication date between January 2005
until the date of the search. The reference lists will be canned to identify
relevant articles that did not appear during the literature search. This search
will result in an overview of the latest opinions with insight in
state-of-the-art management of traumatic spleen injury.
The total duration of the project is 48 months.

Questionnaires quality of life (all patients):
If patients have an Internet connection, they will fill in the questionnaires
online. This will take approximately 15-30 minutes. If patients do not have an
Internet connection, they will receive the questionnaires by post. This will
possibly take more time.

MRI scan of the abdomen (only patients who have been treated with embolization
of the splenic artery):
Patients will be called for a voluntary one-time MRI abdomen in the St.
Elisabeth Hospital in Tilburg. Undergoing an MRI scan of the abdomen could be
uncomfortable and may cause some physical and psychological discomfort. There
are no known harmful or biological effects. Prior to the scan,
contraindications for MRI will be excluded. Doing an MRI scan is necessary for
this study to assess the spleen morphology after embolization of the splenic
artery.
The MRI examination will take approximately 45 minutes.