Traumatic Splenic Injury and Management (SPLENIQ Study)
NCT ID: NCT03099798
Last Updated: 2022-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
106 participants
OBSERVATIONAL
2017-03-01
2020-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Non-Operative Management (NOM)/Observational
Patients "treated" observationally for (traumatic) spleen injury.
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.
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
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.
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
Interventions
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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
MRI abdomen
Patients who were treated with splenic artery embolization will also undergo an MRI one month and one year after treatment.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Maasstad Hospital
OTHER
Albert Schweitzer Hospital
OTHER
Amphia Hospital
OTHER
Tilburg University
OTHER
Leiden University Medical Center
OTHER
Amsterdam UMC, location VUmc
OTHER
Medisch Spectrum Twente
OTHER
Radboud University Medical Center
OTHER
Isala
OTHER
Elisabeth-TweeSteden Ziekenhuis
OTHER
Responsible Party
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Principal Investigators
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Jolanda de Vries, Prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Project leader (ETZ Tilburg, Tilburg University)
Locations
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Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Amphia Hospital
Breda, North Brabant, Netherlands
Elisabeth-Twee Steden Hospital
Tilburg, North Brabant, Netherlands
VU University Medical Center
Amsterdam, North Holland, Netherlands
Medical Spectrum Twente
Enschede, Overijssel, Netherlands
Isala
Zwolle, Overijssel, Netherlands
Albert Schweitzer Hospital
Dordrecht, South Holland, Netherlands
Leiden University Medical Center
Leiden, South Holland, Netherlands
Erasmus MC
Rotterdam, South Holland, Netherlands
Maasstad Hospital
Rotterdam, South Holland, Netherlands
Countries
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References
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Raaijmakers CP, Lohle PN, Lodder P, de Vries J. Quality of Life and Clinical Outcome After Traumatic Spleen Injury (SPLENIQ Study): Protocol for an Observational Retrospective and Prospective Cohort Study. JMIR Res Protoc. 2019 Apr 26;8(5):e12391. doi: 10.2196/12391.
Related Links
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Other Identifiers
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NL54542.028.16 / P1609
Identifier Type: -
Identifier Source: org_study_id
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