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

NCT ID: NCT03890328

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-01
• Study Completion Date: 2014-06-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RF group

radiofrequency-assisted spleen-preserving therapy group.

Group Type: EXPERIMENTAL

radiofrequency ablation

Intervention Type: PROCEDURE

apply RF therapy to the treatment of splenic trauma

CT group

Conventional Treatment of Blunt Splenic Injury group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

radiofrequency ablation

apply RF therapy to the treatment of splenic trauma

Intervention Type: PROCEDURE

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

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Second University Hospital

OTHER

Sponsor Role: collaborator

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

fengkai

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kuansheng Ma, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Institute of hepatobiliary surgery,Southwest Hospital

Locations

Institute of hepatobiliary surgery,Southwest Hospital

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

81672857

Identifier Type: -

Identifier Source: org_study_id