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.

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.

Study Overview

• Status: Completed
• Conditions: Radiofrequency Can be Used to Treat Splenic Trauma Because of Its Excellent Coagulation Hemostasis
• Intervention / Treatment: Procedure: radiofrequency ablation

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Institute of hepatobiliary surgery,southwest hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean operative time，	Mean operative time of the RF group was compared with that of CT group.	intraoperative
intraoperative bleeding	Intraoperative bleeding of the RF group was compared with that of CT group.	intraoperative

Collaborators and Investigators

• Sponsor: Southwest Hospital, China
• Collaborators: West China Second University Hospital
• Investigators: Principal Investigator: Kuansheng Ma, Ph.D, Institute of hepatobiliary surgery,southwest hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2009
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 24, 2019
• First Posted (ACTUAL): March 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 24, 2019
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: 81672857

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No