JMIR Publications

ABSTRACT

Background:

Little is known about the effect of a splenic rupture on the QOL of patients, while the spleen is one of the most frequently injured organs in blunt abdominal trauma. It is essential to obtain more knowledge about QOL after traumatic splenic injury so this can be taken into account when choosing treatment.

Objective:

The primary aim of the SPLENIQ study is to determine QOL after treatment for traumatic splenic injury. The secondary aim is to investigate clinical and imaging outcome, specifically: (I) examine therapy-related complications, (II) establish the necessity of additional therapies, (III) assess splenic function related to splenic morphology after embolization with Magnetic Resonance Imaging (MRI), (IV) to examine and find additional prognostic factors for failure of non-surgical management in patients with splenic injury, and to (V) conduct the cost-effectiveness of splenic artery embolization (SAE) compared to surgery.

Methods:

A combination of a retrospective single centre and a prospective multicentre observational cohort study will be conducted. Patients in the retrospective study had splenic injury after blunt abdominal trauma and were admitted for treatment to the ETZ Hospital in Tilburg between January 2005 and February 2017. Concerning the prospective cohort study, patients with splenic injury admitted to one of the ten participating hospitals between March 2017 and December 2018 will be asked to participate. The follow-up period will be one year regarding QOL, clinical symptoms, and imaging. Patients in the retrospective study will complete two questionnaires (WHOQOL-Bref and SF-12). Patients in de prospective study will complete five questionnaires at 1 week, 1 month, 3, 6 and 12 months after treatment (WHOQOL-Bref, SF-12, EQ-5D-5L, iPCQ, iMCQ). In both the retrospective and prospective study, patients treated with SAE will undergo an MRI. The retrospective group once and the prospective group one month and one year after treatment. Treatment of splenic injury depends on the severity of the splenic injury, the haemodynamic condition of the patient and the hospital’s/doctor’s preference. This study is observational in nature without randomization. Concerning the retrospective data MANCOVA will be done. With regard to the prospective data mixed linear modelling will be performed.

Results:

This project was funded in April 2015 by ZonMw. The results of the retrospective study are expected halfway 2018. With regard to the prospective study, recruitment is currently ongoing. Data collection will be completed in December 2018. The first results are expected in 2019.

Conclusions:

To our knowledge, this is the first study that examines QOL, clinical, and imaging outcome of patients with traumatic spleen injury. The SPLENIQ study responds to the shortage of information about QOL after treatment for traumatic spleen injury and may result in the development of a patient-oriented protocol. Clinical Trial: ClinicalTrials.gov NCT03099798 by the U.S. National Library of Medicine at the National Institutes of Health; https://clinicaltrials.gov/ct2/show/NCT03099798 Archived by WebCite® at: http://www.webcitation.org/714ZKV6A0