Clinical trial NCT03890328: RF-assisted Splenic Preservation VS Conventional Treatment of Blunt Splenic Injury.
Official title: Radiofrequency-assisted Splenic Preservation Versus Conventional Treatment of Blunt Splenic Injury: A Prospective Cohort Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation Hemostasis
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
Collaborators: name: West China Second University Hospital
First posted: 2019-03-26
Enrollment: 122
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Mean operative time，
timeFrame: intraoperative
measure: intraoperative bleeding
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Institute of hepatobiliary surgery,Southwest Hospital
state: Chongqing
Study officials:
affiliation: Institute of hepatobiliary surgery,Southwest Hospital
name: Kuansheng Ma, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: