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

Not Applicable

Completed

• Conditions: Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation Hemostasis
• Interventions: Procedure: radiofrequency ablation

• Registration Number: NCT03890328
• Lead Sponsor: Southwest Hospital, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-03
• Study Start: 2009-03-01
• Primary Completion: 2014-06-01
• Study Completion: 2014-06-01
• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-24
• Last Update Submitted: 2019-03-24
• Study First Posted: 2019-03-26
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RF group	radiofrequency ablation	radiofrequency-assisted spleen-preserving therapy group.

Primary Outcome Measures

Name	Time	Method
Mean operative time，	intraoperative	Mean operative time of the RF group was compared with that of CT group.
intraoperative bleeding	intraoperative	Intraoperative bleeding of the RF group was compared with that of CT group.

Trial Locations

Locations (1)

Institute of hepatobiliary surgery,Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China