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

NCT03890328 | Completed DMC

• 1 other identifier: 81672857
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

RF group

EXPERIMENTAL

radiofrequency-assisted spleen-preserving therapy group.

Procedure: radiofrequency ablation

CT group

NO INTERVENTION

Conventional Treatment of Blunt Splenic Injury group.

Interventions

radiofrequency ablation PROCEDURE

apply RF therapy to the treatment of splenic trauma

RF group

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southwest Hospital, China: lead
• West China Second University Hospital: collaborator

Study Sites (1)

Institute of hepatobiliary surgery,Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

Location

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Kuansheng Ma, Ph.D

  Institute of hepatobiliary surgery,Southwest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 26, 2019
• Study Start: March 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 26, 2019

Record last verified: 2009-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)