NCT00910182

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 29, 2009

Completed
Last Updated

May 29, 2009

Status Verified

May 1, 2009

Enrollment Period

6.9 years

First QC Date

May 28, 2009

Last Update Submit

May 28, 2009

Conditions

Keywords

Splenic ruptureabdominal injuriesSurgeryAngiographyEmbolisationComputed tomographyClassification

Outcome Measures

Primary Outcomes (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 Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

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

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

Interventions

splenorrhaphyPROCEDURE

surgical treatment of splenic injuries after blunt abdominal trauma.

2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • traumatic splenic rupture
  • years and older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of visceral and transplant surgery, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 2339919BACKGROUND
  • 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.

    PMID: 9605662BACKGROUND
  • 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.

    PMID: 17099516BACKGROUND
  • 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.

    PMID: 10963527BACKGROUND
  • 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.

    PMID: 11706335BACKGROUND

MeSH Terms

Conditions

Splenic RuptureAbdominal Injuries

Condition Hierarchy (Ancestors)

Splenic DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesWounds and InjuriesRupture

Study Officials

  • Pietro Renzulli, MD

    Bern University Hospital, 3010 Bern, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2009

First Posted

May 29, 2009

Study Start

January 1, 2002

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 29, 2009

Record last verified: 2009-05

Locations