Outcome After Conservative and Surgical Treatment of Splenic Injuries After Blunt Abdominal Trauma.

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00910182
First received: May 28, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

Retrospective study in order to investigate the outcome after conservative (with or without transcatheter arterial embolization) and surgical treatment of splenic injuries.


Condition Intervention
Splenic Rupture
Abdominal Injuries
Procedure: splenorrhaphy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Outcome After Conservative and Surgical Treatment of Splenic Injuries After Blunt Abdominal Trauma. Retrospective Study 2002-2008.

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Splenic salvage rate [ Time Frame: Routine follow-up examinations were performed 3 and 6 months after splenic injury. All patients and/or their treating physicians will be contacted in order gather information about the present health status ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of organ-preserving surgery [ Time Frame: Routine follow-up examinations were performed 3 and 6 months after splenic injury. All patients and/or their treating physicians will be contacted in order gather information about the present health status ] [ Designated as safety issue: No ]
  • Percentage of secondary splenic ruptures [ Time Frame: Routine follow-up examinations were performed 3 and 6 months after splenic injury. All patients and/or their treating physicians will be contacted in order gather information about the present health status ] [ Designated as safety issue: No ]
  • Percentage of patients undergoing a non-operative management [ Time Frame: Routine follow-up examinations were performed 3 and 6 months after splenic injury. All patients and/or their treating physicians will be contacted in order gather information about the present health status ] [ Designated as safety issue: No ]
  • Percentage of patients undergoing transcatheter arterial embolisation [ Time Frame: Routine follow-up examinations were performed 3 and 6 months after splenic injury. All patients and/or their treating physicians will be contacted in order gather information about the present health status ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: January 2002
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
all adult patients with splenic rupture after blunt abdominal injuries admitted to Bern University Hospital between January 2002 and December 2008 and treated non-operatively
2
all adult patients with splenic rupture after blunt abdominal injuries admitted to Bern University Hospital between January 2002 and December 2008 who underwent emergency surgical treatment
Procedure: splenorrhaphy
surgical treatment of splenic injuries after blunt abdominal trauma.
3
all adult patients with splenic rupture after blunt abdominal injuries admitted to Bern University Hospital between January 2002 and December 2008 treated non-operatively plus transcatheter arterial embolisation

Detailed Description:

Background

Splenic injuries after blunt abdominal trauma are treated with increasing frequency without operation. Patients undergo observation and bed rest. In certain circumstances an additional transcatheter arterial embolization is performed. It is uncertain which splenic ruptures (injury grades according to Moore) are best treated non-operatively and which are best treated with an emergency operation. Furthermore the value of organ-preserving surgery (splenorrhaphy) is uncertain. In addition, the importance of transcatheter arterial embolisation is unknown.

Objective

Evaluation of outcome (splenic salvage rate, complications, survival) after conservative and surgical treatment. Evaluation of the importance of organ-preserving surgery and of transcatheter arterial embolization.

Methods

All adult patients with splenic injuries after blunt abdominal trauma are included (2002-2008). The patients charts are studied and the following main information retrieved: age, gender, mechanism of accident, grade of splenic injury, concomitant injuries, patient management in the emergency department (fluid administration etc.), diagnostic methods (ultrasound, computed tomography), treatment modalities (bed rest, surgery, embolization), complications of treatment, re-operations, long-term outcome.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

all patients suffering from traumatic splenic rupture admitted to Bern University Hospital between January 2002 and December 2008

Criteria

Inclusion Criteria:

  • traumatic splenic rupture
  • 16 years and older
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910182

Locations
Switzerland
Dep. of visceral and transplant surgery, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Pietro Renzulli, MD Bern University Hospital, 3010 Bern, Switzerland
  More Information

Publications:

Responsible Party: Pietro Renzulli MD, Bern University Hospital, Departement of Visceral and Transplant Surgery
ClinicalTrials.gov Identifier: NCT00910182     History of Changes
Other Study ID Numbers: KEK 07-05-09
Study First Received: May 28, 2009
Last Updated: May 28, 2009
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
Splenic rupture
abdominal injuries
Surgery
Angiography
Embolisation
Computed tomography
Classification

Additional relevant MeSH terms:
Splenic Rupture
Abdominal Injuries
Wounds and Injuries
Rupture
Splenic Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014