Institute of hepatobiliary surgery,Southwest Hospital
Chongqing, Chongqing Municipality, 400038, China
Completed
NCT Number: NCT03890328
RF-assisted Splenic Preservation VS Conventional Treatment of Blunt Splenic Injury.
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.
Completed
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Notify MeKey information
Conditions
Age range
Up to 70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
：
- age below 70
- 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
- patients transferred directly to the trauma center after injury who had not been treated by any specific spleen-directed therapy in the transferring hospital
- AAST grade II splenic injury with hemodynamic instability or progressive bleeding requiring active intervention
- AAST grade Ⅲ-Ⅳsplenic injury, or splenic laceration involving less than 50% of the splenic parenchyma
Exclusion criteria
- penetrating abdominal injury
- concomitant organ injury with an abbreviated injury scale (AIS) greater than 4 that threatened the life of the patient
- 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
- patients who had failed NOM
- patients with pathologic splenic rupture
Treatment and study plan
Radiofrequency ablation
Procedureapply RF therapy to the treatment of splenic trauma
Primary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Southwest Hospital, China
Other
Collaborators
- West China Second University Hospital
Registry information
Official study title
Radiofrequency-assisted Splenic Preservation Versus Conventional Treatment of Blunt Splenic Injury: A Prospective Cohort Study.
Important dates
- Study start
- 2009
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Mar 26, 2019
- Registry last updated
- Mar 26, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.