Nonoperative Management Protocol in Patients With Blunt Splenic Injuries

Is Strict Adherence to the Nonoperative Management Protocol Associated With Better Outcome in Patients With Blunt Splenic Injuries

This study was designed to explore the adverse events and associated risk factors before and after protocol-based NOM of BSI over a 12-year period in our institution.

Study Overview

• Status: Completed
• Conditions: Blunt Injuries
• Intervention / Treatment: Other: Patient before cohort (2005-2010); Other: Patient after cohort (2011-2016)

Detailed Description

The nonoperative management (NOM) protocol with angioembolization (AE) presents a trend in dealing with trauma patients with blunt splenic injury (BSI). This study was designed to explore the adverse events and associated risk factors before and after protocol-based NOM of BSI over a 12-year period.

• Study Type: Observational
• Enrollment (Actual): 399

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A retrospective study was performed on adult trauma patients with BSI who were admitted from 2005 to 2016. The patients were divided into before cohort (2005-2010) and after cohort (2011-2016).

Description

Inclusion Criteria:

• Adult trauma patients with blunt splenic injury who were admitted from 2005 to 2016.

Exclusion Criteria:

• Patients younger than 16 years
• Patients who died in the emergency department

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nonoperative management protocol with angioembolization; The nonoperative management (NOM) protocol with angioembolization (AE) presents a trend in dealing with trauma patients with blunt splenic injury (BSI). This study was designed to explore the adverse events and associated risk factors before and after protocol-based NOM of BSI over a 12-year period.	Other: Patient before cohort (2005-2010); The NOM protocol with AE was recognized and accepted after our previous study reported in 2004.; Other: Patient after cohort (2011-2016); The protocol of NOM became more aggressively and strictly adhered to since 2011.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The numbers of associated complications and mortality	The primary outcome of interest in this study would be the associated complications and mortality.	up to 6 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Chair: TSANG-TANG Hsieh, MD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): October 30, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Wounds, Nonpenetrating
• Other Study ID Numbers: 102-4441B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No