RF-assisted Splenic Preservation VS Conventional Treatment of Blunt Splenic Injury.
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|ClinicalTrials.gov Identifier: NCT03890328|
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation Hemostasis||Procedure: radiofrequency ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Radiofrequency-assisted Splenic Preservation Versus Conventional Treatment of Blunt Splenic Injury: A Prospective Cohort Study.|
|Actual Study Start Date :||March 1, 2009|
|Actual Primary Completion Date :||June 1, 2014|
|Actual Study Completion Date :||June 1, 2014|
Experimental: RF group
radiofrequency-assisted spleen-preserving therapy group.
Procedure: radiofrequency ablation
apply RF therapy to the treatment of splenic trauma
No Intervention: CT group
Conventional Treatment of Blunt Splenic Injury group.
- Mean operative time， [ Time Frame: intraoperative ]Mean operative time of the RF group was compared with that of CT group.
- intraoperative bleeding [ Time Frame: intraoperative ]Intraoperative bleeding of the RF group was compared with that of CT group.
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): NCT03890328
|Institute of hepatobiliary surgery,Southwest Hospital|
|Chongqing, Chongqing, China, 400038|
|Principal Investigator:||Kuansheng Ma, Ph.D||Institute of hepatobiliary surgery,Southwest Hospital|