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

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Completed
CT.gov ID
NCT00910182
Collaborator
(none)
200
1
83
2.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: splenorrhaphy

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.

Study Design

Study Type:
Observational
Actual Enrollment :
200 participants
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.
Study Start Date :
Jan 1, 2002
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Splenic salvage rate [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]

Secondary Outcome Measures

  1. Rate of organ-preserving surgery [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]

  2. Percentage of secondary splenic ruptures [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]

  3. Percentage of patients undergoing a non-operative management [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]

  4. Percentage of patients undergoing transcatheter arterial embolisation [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • traumatic splenic rupture

  • 16 years and older

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00910182
Other Study ID Numbers:
  • KEK 07-05-09
First Posted:
May 29, 2009
Last Update Posted:
May 29, 2009
Last Verified:
May 1, 2009

Study Results

No Results Posted as of May 29, 2009