Traumatic Splenic Injury and Management (SPLENIQ Study)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Non-Operative Management (NOM)/Observational Patients "treated" observationally for (traumatic) spleen injury. |
Other: Questionnaires
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
|
| Splenic Artery Embolization Patients treated with splenic artery embolization for (traumatic) spleen injury. |
Other: Questionnaires
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
Diagnostic Test: MRI abdomen
Patients who were treated with splenic artery embolization will also undergo an MRI one month and one year after treatment.
|
| Surgery Patients treated surgically for (traumatic) spleen injury. |
Other: Questionnaires
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
|
Outcome Measures
Primary Outcome Measures
- 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: 1 month follow-up [One month after treatment]
WHOQoL-Bref questionnaire
- Quality of life: 3 months follow-up [Three months after treatment]
WHOQoL-Bref questionnaire
- Quality of life: 6 months follow-up [Six months after treatment]
WHOQoL-Bref questionnaire
- Quality of life: one year follow-up [One year 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
- 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
Secondary Outcome Measures
- 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)
- Cost-effectiveness [One year follow-up]
The overall cost-effectiveness will be assessed with the iPCQ and iMCQ questionnaires, completed at different time points
- 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
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Radboud University Medical Center | Nijmegen | Gelderland | Netherlands | 6525 GA |
| 2 | Amphia Hospital | Breda | Noord-Brabant | Netherlands | 4800 RL |
| 3 | Elisabeth-Twee Steden Hospital | Tilburg | Noord-Brabant | Netherlands | 5000 LC |
| 4 | VU University Medical Center | Amsterdam | Noord-Holland | Netherlands | 1081 HV |
| 5 | Medical Spectrum Twente | Enschede | Overijssel | Netherlands | 7512 KZ |
| 6 | Isala | Zwolle | Overijssel | Netherlands | 8025 AB |
| 7 | Albert Schweitzer Hospital | Dordrecht | Zuid-Holland | Netherlands | 3300 AK |
| 8 | Leiden University Medical Center | Leiden | Zuid-Holland | Netherlands | 2333 ZA |
| 9 | Erasmus MC | Rotterdam | Zuid-Holland | Netherlands | 3000 CA |
| 10 | Maasstad Hospital | Rotterdam | Zuid-Holland | Netherlands | 3007 AC |
Sponsors and Collaborators
- Elisabeth-TweeSteden Ziekenhuis
- Erasmus Medical Center
- Maasstad Hospital
- Albert Schweitzer Hospital
- Amphia Hospital
- Tilburg University
- Leiden University Medical Center
- Amsterdam UMC, location VUmc
- Medisch Spectrum Twente
- Radboud University Medical Center
- Isala
Investigators
- Principal Investigator: Jolanda de Vries, Prof. dr., Project leader (ETZ Tilburg, Tilburg University)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- NL54542.028.16 / P1609