Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00910182
Other study ID # KEK 07-05-09
Secondary ID
Status Completed
Phase N/A
First received May 28, 2009
Last updated May 28, 2009
Start date January 2002
Est. completion date December 2008

Study information

Verified date May 2009
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- traumatic splenic rupture

- 16 years and older

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Procedure:
splenorrhaphy
surgical treatment of splenic injuries after blunt abdominal trauma.

Locations

Country Name City State
Switzerland Dep. of visceral and transplant surgery, Bern University Hospital Bern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
See also
  Status Clinical Trial Phase
Terminated NCT02542241 - Hypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control Phase 4
Active, not recruiting NCT03473249 - Effectiveness of Contrast-Enhanced Ultrasound Phase 4
Completed NCT04534816 - Feasibility and Usability of Intraoperative Fluorescent Angiography With Indocyanine Green in Penetrating Abdominal Trauma N/A
Completed NCT00228111 - TRACT Study: Evaluation of the Value of Routine Thoraco-abdominal CT in Blunt Trauma Patients N/A
Completed NCT02831556 - Point of Care 3D Ultrasound for Various Applications: A Pilot Study
Recruiting NCT02829125 - Influence of Postoperative Rehabilitation and Pre- and Postoperative Physical Activity in Abdominal Surgery N/A
Completed NCT01540318 - Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma N/A
Completed NCT01268514 - ENHANCE: A Prospective EvaluatioN of Permacolâ„¢ in tHe Repair of Complex AbdomiNal Wall CasEs
Terminated NCT00295438 - Robot-based Tele-echography II - A Comparative Study N/A