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Traumatic Splenic Injury and Management "Quality of Life and Clinical Outcomes of Treatment for Splenic Injury after Trauma" Retrospective study

Traumatic Splenic Injury and Management "Quality of Life and Clinical Outcomes of Treatment for Splenic Injury after Trauma" Retrospective study - SPLENIQ study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42351
Enrollment
175
Registered
2016-01-27
Start date
2016-09-17
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Splenic injury splenic laceration

Interventions

None listed

Sponsors

Sint Elisabeth Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients: - With splenic injury after blunt abdominal trauma - Currently 18 years or older - For MRI: treated with splenic artery embolization (approximately 30 patients) Retrospective: January 2005 to now

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
(I) RETROSPECTIVE PRIMARY Quality of life is assessed with the generic 26-item World Health Organization Quality of Life-Bref (WHOQOL-Bref) [14]. This measure assesses four domains (Physical health, Psychological health, Social relationships, and Environment) and a general facet *Overall QOL and general health*. The short-form (12) health survey is a shorter version of the SF-36, which is used to evaluate individual patients health status, researching the cost-effectiveness of a treatment and monitoring and comparing disease burden.

Secondary

MeasureTime frame
(I) RETROSPECTIVE SECONDARY Furthermore the three treatments will be compared in terms of clinical outcomes, recovery related outcomes and cost outcomes. Also imaging outcomes will be investigated in the SAE group, thereby identifying morphological (versus immunological) aspects of the spleen after endovascular treatment. The following endpoints apply to each of the outcomes: - Clinical: complications during and/or after treatment; failure rate (technical, clinical); any re-intervention or additional therapy - Recovery related: hospital stay (days) - Imaging: how does the spleen morphologically look like, in patients who underwent embolization treatment of the splenic artery in case of traumatic splenic injury? Splenic morpholical characteristics such as: volume; necrosis; splenosis; calcifications; chronic infarction morphology Reference data from the manuals of the associated questionnaires will serve as a control group. Results of the comparison between our retrospective group and the reference data will be used for the design of the prospective study.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)