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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00910182
First Posted: May 29, 2009
Last Update Posted: May 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Inselspital, Berne
  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 ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Pachter HL, Spencer FC, Hofstetter SR, Liang HG, Hoballah J, Coppa GF. Experience with selective operative and nonoperative treatment of splenic injuries in 193 patients. Ann Surg. 1990 May;211(5):583-9; discussion 589-91.
Pachter HL, Guth AA, Hofstetter SR, Spencer FC. Changing patterns in the management of splenic trauma: the impact of nonoperative management. Ann Surg. 1998 May;227(5):708-17; discussion 717-9.
Watson GA, Rosengart MR, Zenati MS, Tsung A, Forsythe RM, Peitzman AB, Harbrecht BG. Nonoperative management of severe blunt splenic injury: are we getting better? J Trauma. 2006 Nov;61(5):1113-8; discussion 1118-9.
Peitzman AB, Heil B, Rivera L, Federle MB, Harbrecht BG, Clancy KD, Croce M, Enderson BL, Morris JA, Shatz D, Meredith JW, Ochoa JB, Fakhry SM, Cushman JG, Minei JP, McCarthy M, Luchette FA, Townsend R, Tinkoff G, Block EF, Ross S, Frykberg ER, Bell RM, Davis F 3rd, Weireter L, Shapiro MB. Blunt splenic injury in adults: Multi-institutional Study of the Eastern Association for the Surgery of Trauma. J Trauma. 2000 Aug;49(2):177-87; discussion 187-9.
Harbrecht BG, Peitzman AB, Rivera L, Heil B, Croce M, Morris JA Jr, Enderson BL, Kurek S, Pasquale M, Frykberg ER, Minei JP, Meredith JW, Young J, Kealey GP, Ross S, Luchette FA, McCarthy M, Davis F 3rd, Shatz D, Tinkoff G, Block EF, Cone JB, Jones LM, Chalifoux T, Federle MB, Clancy KD, Ochoa JB, Fakhry SM, Townsend R, Bell RM, Weireter L, Shapiro MB, Rogers F, Dunham CM, McAuley CE. Contribution of age and gender to outcome of blunt splenic injury in adults: multicenter study of the eastern association for the surgery of trauma. J Trauma. 2001 Nov;51(5):887-95.

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
First Submitted: May 28, 2009
First Posted: May 29, 2009
Last Update Posted: May 29, 2009
Last Verified: May 2009

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

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


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