Traumatic Splenic Injury and Management (SPLENIQ Study)

Quality of Life Clinical Trial

— SPLENIQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099798
• Other study ID #: NL54542.028.16 / P1609
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2022
• Source: Elisabeth-TweeSteden Ziekenhuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Quality of Life
• Spleen Injury
• Splenic Artery Embolization
• Trauma
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam	Noord-Holland
Netherlands	Amphia Hospital	Breda	Noord-Brabant
Netherlands	Albert Schweitzer Hospital	Dordrecht	Zuid-Holland
Netherlands	Medical Spectrum Twente	Enschede	Overijssel
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland
Netherlands	Radboud University Medical Center	Nijmegen	Gelderland
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland
Netherlands	Maasstad Hospital	Rotterdam	Zuid-Holland
Netherlands	Elisabeth-Twee Steden Hospital	Tilburg	Noord-Brabant
Netherlands	Isala	Zwolle	Overijssel

Sponsors (11)

Lead Sponsor	Collaborator
Elisabeth-TweeSteden Ziekenhuis	Albert Schweitzer Hospital, Amphia Hospital, Amsterdam UMC, location VUmc, Erasmus Medical Center, Isala, Leiden University Medical Center, Maasstad Hospital, Medisch Spectrum Twente, Radboud University Medical Center, Tilburg University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life: baseline (within 1 week after treatment)	WHOQoL-Bref questionnaire, SF-12 and EQ-5D-5L questionnaires	One week after treatment
Primary	Quality of life: 1 month follow-up	WHOQoL-Bref questionnaire	One month after treatment
Primary	Quality of life: 3 months follow-up	WHOQoL-Bref questionnaire	Three months after treatment
Primary	Quality of life: 6 months follow-up	WHOQoL-Bref questionnaire	Six months after treatment
Primary	Quality of life: one year follow-up	WHOQoL-Bref questionnaire	One year after treatment
Primary	Change in health status: SF-12	SF-12 questionnaire	One week, 1 month and 3, 6 and 12 months after treatment
Primary	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	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
Secondary	Cost-effectiveness	The overall cost-effectiveness will be assessed with the iPCQ and iMCQ questionnaires, completed at different time points	One year follow-up
Secondary	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
Secondary	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
Secondary	Splenic Artery Embolization characteristics	Difference between proximal versus distal embolization	One year follow-up
Secondary	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

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