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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890328
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
West China Second University Hospital
Information provided by (Responsible Party):
fengkai, 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.


Condition or disease Intervention/treatment Phase
Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation Hemostasis Procedure: radiofrequency ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiofrequency-assisted Splenic Preservation Versus Conventional Treatment of Blunt Splenic Injury: A Prospective Cohort Study.
Actual Study Start Date : March 1, 2009
Actual Primary Completion Date : June 1, 2014
Actual Study Completion Date : June 1, 2014

Arm Intervention/treatment
Experimental: RF group
radiofrequency-assisted spleen-preserving therapy group.
Procedure: radiofrequency ablation
apply RF therapy to the treatment of splenic trauma

No Intervention: CT group
Conventional Treatment of Blunt Splenic Injury group.



Primary Outcome Measures :
  1. Mean operative time, [ Time Frame: intraoperative ]
    Mean operative time of the RF group was compared with that of CT group.

  2. intraoperative bleeding [ Time Frame: intraoperative ]
    Intraoperative bleeding of the RF group was compared with that of CT group.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890328


Locations
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China, Chongqing
Institute of hepatobiliary surgery,Southwest Hospital
Chongqing, Chongqing, China, 400038
Sponsors and Collaborators
Southwest Hospital, China
West China Second University Hospital
Investigators
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Principal Investigator: Kuansheng Ma, Ph.D Institute of hepatobiliary surgery,Southwest Hospital
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Responsible Party: fengkai, associate professor, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT03890328    
Other Study ID Numbers: 81672857
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2009
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No