Traumatic Splenic Injury and Management (SPLENIQ Study)

Study Overview
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Brief Summary
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OBJECTIVE: To determine the quality of life (QOL) and clinical outcome after conservative therapy, embolization (proximal versus distal) or surgery in patients with traumatic splenic injury. Secondary aims: (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 embolization 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. HYPOTHESIS: The investigators expect that NOM is superior to surgery with regard to QOL, clinical outcome and splenic function. Embolization will need more additional therapies. Splenic morphology is related to splenic immune function. Expected prognostic factors are age above 40, ISS >25 and a splenic injury grade of 3 or higher. STUDY DESIGN: A combination of a retrospective and a prospective multicentre cohort study. This protocol involves the prospective part of the study. STUDY POPULATION/DATASET: Patients who enter the participating hospitals between March 2017 and December 2018 with splenic injury will be asked to participate. The follow-up period will be one year with regard to QOL, clinical symptoms and imaging. INTERVENTION: All patients will complete a number of questionnaires at different time points. The patients who were treated with splenic artery embolization (SAE) will undergo an MRI one month and one year after treatment. OUTCOME MEASURES: Primary outcome is QOL. Secondary outcomes are clinical symptoms and imaging. SAMPLE SIZE: Approximately 100 patients will be included per year during the inclusion phase. DATA ANALYSIS: With regard to the prospective data linear modelling will be performed. COLLABORATION/CONNECTION: Tilburg University, Erasmus Medical Center Rotterdam, Maasstad Hospital Rotterdam, Albert Schweitzer Hospital Dordrecht, Amphia hospital Breda, Leiden University Medical Center, VU University Medical Center Amsterdam, Medical Spectrum Twente, Radboud University Nijmegen, Isala Zwolle. TIME SCHEDULE: Year 1: literature search and conducting the retrospective study and analyses. Years 1-3: inclusion prospective study and follow-up of patients. Year 4: finishing follow-up data collection and analysing.

Official Title
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Traumatic Splenic Injury and Management (SPLENIQ Study) Quality of Life and Clinical Outcomes of Treatment for Splenic Injury After Trauma

Conditions
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Quality of Life, Spleen Injury, Trauma, Splenic Artery Embolization

Intervention / Treatment
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* Other: Questionnaires
* Diagnostic Test: MRI abdomen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Splenic injury after blunt abdominal trauma (confirmed by FAST and/or CT) The patient underwent NOM/SAE/splenectomy for the management of traumatic splenic injury The treatment took place in the period from March 2017 to December 2018 at one of the five selected hospitals 18 years or older. Exclusion Criteria: Insufficient knowledge of the Dutch language Patients who died during or after treatment are (of course) excluded for questionnaires and MRI, not for clinical outcomes Exclusion for MRI only: - Patients treated with SAE: patients who do not want to or are not able to undergo an MRI abdomen (for example pregnant women or other contraindications for MRI). Patients excluded for MRI still need to fill out the questionnaires. Also, their clinical outcomes will be processed in the database.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-Operative Management (NOM)/Observational<br>Patients treated observationally for (traumatic) spleen injury. | Other: Questionnaires<br>* All patients will complete a number of questionnaires at different time points. SF-12, WHOQoL-Bref, EQ-5D-5L, iPCQ, iMCQ 1 week, 1 month, 3, 6 and 12 months after treatment<br>|
| Splenic Artery Embolization<br>Patients treated with splenic artery embolization for (traumatic) spleen injury. | Other: Questionnaires<br>* All patients will complete a number of questionnaires at different time points. SF-12, WHOQoL-Bref, EQ-5D-5L, iPCQ, iMCQ 1 week, 1 month, 3, 6 and 12 months after treatment<br>Diagnostic Test: MRI abdomen<br>* Patients who were treated with splenic artery embolization will also undergo an MRI one month and one year after treatment.<br>|
| Surgery<br>Patients treated surgically for (traumatic) spleen injury. | Other: Questionnaires<br>* All patients will complete a number of questionnaires at different time points. SF-12, WHOQoL-Bref, EQ-5D-5L, iPCQ, iMCQ 1 week, 1 month, 3, 6 and 12 months after treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life: baseline (within 1 week after treatment) | WHOQoL-Bref questionnaire, SF-12 and EQ-5D-5L questionnaires | One week after treatment | 
| Quality of life: 1 month follow-up | WHOQoL-Bref questionnaire | One month after treatment | 
| Quality of life: 3 months follow-up | WHOQoL-Bref questionnaire | Three months after treatment | 
| Quality of life: 6 months follow-up | WHOQoL-Bref questionnaire | Six months after treatment | 
| Quality of life: one year follow-up | WHOQoL-Bref questionnaire | One year after treatment | 
| Change in health status: SF-12 | SF-12 questionnaire | One week, 1 month and 3, 6 and 12 months after treatment | 
| Change in health related quality of life: EQ-5D-5L | EQ-5D-5L questionnaire | One week, 1 month and 3, 6 and 12 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome | Data obtained from the patient records (e.g. complications, need for re-intervention, hospital stay, return to daily activities) | One year follow-up | 
| Cost-effectiveness | The overall cost-effectiveness will be assessed with the iPCQ and iMCQ questionnaires, completed at different time points | One year follow-up | 
| Imaging Outcome after Embolization (one month after treatment) | Splenic morphological characteristics (e.g. volume, necrosis, splenosis, calcifications or chronic infarction morphology) | One month after embolization | 
| Imaging Outcome after Embolization (one year after treatment) | Splenic morphological characteristics (e.g.volume, necrosis, splenosis, calcifications or chronic infarction morphology) | One year after embolization | 
| Splenic Artery Embolization characteristics | Difference between proximal versus distal embolization | One year follow-up | 
| Prognostic factors for failure of Non-Operative Management | 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. | One year follow-up |