RF-assisted Splenic Preservation VS Conventional Treatment of Blunt Splenic Injury.

Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation Hemostasis Clinical Trial

Official title:

Radiofrequency-assisted Splenic Preservation Versus Conventional Treatment of Blunt Splenic Injury: A Prospective Cohort Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03890328
• Other study ID #: 81672857
• Status: Completed
• Phase: N/A
• Start date: March 1, 2009
• Est. completion date: June 1, 2014

Study information

• Verified date: March 2009
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Radiofrequency (RF) can be used to treat splenic trauma because of its excellent coagulation hemostasis. This study aimed to compare the efficacy of RF-assisted spleen-preserving surgery with that of conventional splenorrhaphy/splenectomy in the treatment of blunt splenic injury.

A total of 122 patients with splenic trauma admitted to two tertiary referral centers from June 2011 to June 2014 were included in this prospective cohort study. The 67 patients at one center were treated by radiofrequency-assisted spleen-preserving therapy (RF group), and the 55 patients admitted at the other center underwent conventional treatment (CT group). Demographics and clinical characteristics of the two groups were comparable.

Compared to traditional splenorrhaphy and splenectomy, RF-assisted splenic hemostasis and salvage was safe, effective and easy to use in the treatment of splenic injuries. In particular for high-grade splenic injuries, these techniques preserved sufficient splenic tissue without any increase in patients with surgical risk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 1, 2014
• Est. primary completion date: June 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

Inclusion Criteria:

1. age below 70

2. blunt abdominal injury combined with indication of post-traumatic splenectomy according to the guidelines provided by the Society for Surgery of the Alimentary Tract in 2005

3. patients transferred directly to the trauma center after injury who had not been treated by any specific spleen-directed therapy in the transferring hospital

4. AAST grade II splenic injury with hemodynamic instability or progressive bleeding requiring active intervention

5. AAST grade ?-?splenic injury, or splenic laceration involving less than 50% of the splenic parenchyma

Exclusion Criteria:

1. penetrating abdominal injury

2. concomitant organ injury with an abbreviated injury scale (AIS) greater than 4 that threatened the life of the patient

3. excessive vascular injury to the splenic pedicle or substantial devitalized splenic tissues when it was expected in when less than 25% of the spleen could be preserved

4. patients who had failed NOM

5. patients with pathologic splenic rupture

Related Conditions & MeSH terms

• Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation Hemostasis

Intervention

Procedure:
• radiofrequency ablation
apply RF therapy to the treatment of splenic trauma

Locations

Country	Name	City	State
China	Institute of hepatobiliary surgery,Southwest Hospital	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Hospital, China	West China Second University Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean operative time,	Mean operative time of the RF group was compared with that of CT group.	intraoperative
Primary	intraoperative bleeding	Intraoperative bleeding of the RF group was compared with that of CT group.	intraoperative