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NCT Number: NCT00910182

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

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

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Key information

Conditions

Splenic Rupture Abdominal Injuries Hemic and Lymphatic Diseases Lymphatic Diseases Rupture Splenic Diseases Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of visceral and transplant surgery, Bern University Hospital

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • traumatic splenic rupture
  • 16 years and older

Treatment and study plan

splenorrhaphy

Procedure

surgical treatment of splenic injuries after blunt abdominal trauma.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Outcome After Conservative and Surgical Treatment of Splenic Injuries After Blunt Abdominal Trauma. Retrospective Study 2002-2008.

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
May 29, 2009
Registry last updated
May 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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