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

Army Medical University

Status: Completed

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

Treatments: Procedure: radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03890328

81672857

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 Ⅲ-Ⅳsplenic 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

RF group

Experimental group

Description:

radiofrequency-assisted spleen-preserving therapy group.

Treatment:

Procedure: radiofrequency ablation

CT group

No Intervention group

Description:

Conventional Treatment of Blunt Splenic Injury group.