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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03890328
Enrollment
122
Registered
2019-03-26
Start date
2009-03-01
Completion date
2014-06-01
Last updated
2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREradiofrequency ablation

apply RF therapy to the treatment of splenic trauma

Sponsors

West China Second University Hospital
CollaboratorOTHER
Southwest Hospital, China
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean operative time,intraoperativeMean operative time of the RF group was compared with that of CT group.
intraoperative bleedingintraoperativeIntraoperative bleeding of the RF group was compared with that of CT group.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026