Traumatic Splenic Injury and Management (SPLENIQ Study)
- Conditions
- Spleen InjuryQuality of LifeTraumaSplenic Artery Embolization
- Interventions
- Other: QuestionnairesDiagnostic Test: MRI abdomen
- Registration Number
- NCT03099798
- Lead Sponsor
- Elisabeth-TweeSteden Ziekenhuis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Splenic Artery Embolization MRI abdomen Patients treated with splenic artery embolization for (traumatic) spleen injury. Splenic Artery Embolization Questionnaires Patients treated with splenic artery embolization for (traumatic) spleen injury. Surgery Questionnaires Patients treated surgically for (traumatic) spleen injury. Non-Operative Management (NOM)/Observational Questionnaires Patients "treated" observationally for (traumatic) spleen injury.
- Primary Outcome Measures
Name Time Method Quality of Life: baseline (within 1 week after treatment) One week after treatment WHOQoL-Bref questionnaire, SF-12 and EQ-5D-5L questionnaires
Quality of life: 6 months follow-up Six months after treatment WHOQoL-Bref questionnaire
Change in health status: SF-12 One week, 1 month and 3, 6 and 12 months after treatment SF-12 questionnaire
Quality of life: 1 month follow-up One month after treatment WHOQoL-Bref questionnaire
Quality of life: one year follow-up One year after treatment WHOQoL-Bref questionnaire
Change in health related quality of life: EQ-5D-5L One week, 1 month and 3, 6 and 12 months after treatment EQ-5D-5L questionnaire
Quality of life: 3 months follow-up Three months after treatment WHOQoL-Bref questionnaire
- Secondary Outcome Measures
Name Time Method Clinical Outcome One year follow-up Data obtained from the patient records (e.g. complications, need for re-intervention, hospital stay, return to daily activities)
Imaging Outcome after Embolization (one month after treatment) One month after embolization Splenic morphological characteristics (e.g. volume, necrosis, splenosis, calcifications or chronic infarction morphology)
Imaging Outcome after Embolization (one year after treatment) One year after embolization Splenic morphological characteristics (e.g.volume, necrosis, splenosis, calcifications or chronic infarction morphology)
Splenic Artery Embolization characteristics One year follow-up Difference between proximal versus distal embolization
Cost-effectiveness One year follow-up The overall cost-effectiveness will be assessed with the iPCQ and iMCQ questionnaires, completed at different time points
Prognostic factors for failure of Non-Operative Management One year follow-up 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.
Trial Locations
- Locations (10)
Albert Schweitzer Hospital
🇳🇱Dordrecht, Zuid-Holland, Netherlands
Maasstad Hospital
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Medical Spectrum Twente
🇳🇱Enschede, Overijssel, Netherlands
Elisabeth-Twee Steden Hospital
🇳🇱Tilburg, Noord-Brabant, Netherlands
Erasmus MC
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Radboud University Medical Center
🇳🇱Nijmegen, Gelderland, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Zuid-Holland, Netherlands
Amphia Hospital
🇳🇱Breda, Noord-Brabant, Netherlands
VU University Medical Center
🇳🇱Amsterdam, Noord-Holland, Netherlands
Isala
🇳🇱Zwolle, Overijssel, Netherlands