Clinical trial NCT00910182: Outcome After Conservative and Surgical Treatment of Splenic Injuries After Blunt Abdominal Trauma.
Official title: Outcome After Conservative and Surgical Treatment of Splenic Injuries After Blunt Abdominal Trauma. Retrospective Study 2002-2008.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Splenic Rupture
Abdominal Injuries
Keywords: Splenic rupture
abdominal injuries
Surgery
Angiography
Embolisation
Computed tomography
Classification
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2009-05-29
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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

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 criteria: Inclusion Criteria:

* traumatic splenic rupture
* 16 years and older

Primary outcomes:
measure: Splenic salvage rate
timeFrame: 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:
measure: Rate of organ-preserving surgery
timeFrame: 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
measure: Percentage of secondary splenic ruptures
timeFrame: 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
measure: Percentage of patients undergoing a non-operative management
timeFrame: 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
measure: Percentage of patients undergoing transcatheter arterial embolisation
timeFrame: 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
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dep. of visceral and transplant surgery, Bern University Hospital
Study officials:
affiliation: Bern University Hospital, 3010 Bern, Switzerland
name: Pietro Renzulli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/00000658-199005000-00008.
citation: 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. doi: 10.1097/00000658-199805000-00011.
citation: 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. doi: 10.1097/01.ta.0000241363.97619.d6.
citation: 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. doi: 10.1097/00005373-200008000-00002.
citation: 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. doi: 10.1097/00005373-200111000-00010.