Traumatic Injury of Spleen:Laparoscopic Splenectomy Vs Splenic Artery Embolization

NCT ID: NCT07274007

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-11-30

Brief Summary

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The goal of this clinical trial is selection of the best method in management of grade 3 traumatic Splenic Injury in Hemodynamically Stable Patients thus improving the quality of life and clinical outcome. The main questions it aims to answer are

1. Assess the quality of life and clinical outcome after using laparoscopic Splenectomy in management of grade 3 traumatic Splenic Injury in Hemodynamically Stable Patients
2. Assess the quality of life and clinical outcome after using Splenic Artery Embolization in management of grade 3 traumatic Splenic Injury in Hemodynamically Stable Patients

Researchers will compare the quality of life and clinical outcome to see if it is better using laparoscopic Splenectomy Splenic Artery Embolization

Participants will underwent laparoscopic Splenectomy or Splenic Artery Embolization and will undwent post operative follow up, follow up at outpatient clinic and will be asked about changes occurring to their daily life social activities and their quality of life

Detailed Description

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Conditions

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Grade III Traumatic Splenic Injury in Hemodynamically Stable Patients

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Laparoscopic Splenectomy

Group Type ACTIVE_COMPARATOR

Laparoscopic Splenectomy vs splenic Artery Embolization

Intervention Type PROCEDURE

Compare the quality of life and clinical outcome after using laparoscopic Splenectomy and Splenic Artery Embolization in management of grade 3 traumatic Splenic Injury in Hemodynamically Stable Patients

Splenic Artery Embolization

Group Type ACTIVE_COMPARATOR

Laparoscopic Splenectomy vs splenic Artery Embolization

Intervention Type PROCEDURE

Compare the quality of life and clinical outcome after using laparoscopic Splenectomy and Splenic Artery Embolization in management of grade 3 traumatic Splenic Injury in Hemodynamically Stable Patients

Interventions

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Laparoscopic Splenectomy vs splenic Artery Embolization

Compare the quality of life and clinical outcome after using laparoscopic Splenectomy and Splenic Artery Embolization in management of grade 3 traumatic Splenic Injury in Hemodynamically Stable Patients

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients aged above 12 years at time of screening.
* Patients diagnosed with grade three traumatic Splenic Injury

Exclusion Criteria

* Patients aged less than 12 years at time of screening .
* Patients diagnosed with associated visceral injury such as "liver,kidney,bowel, etc..".
* Patients diagnosed with isolated splenic injury after trauma other than grades III
* Patients contraindicated for radiological investigations or splenic artery embolization using interventional radiology such as pregnany
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zagazig university,Faculty of medicine

Zagazig, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ZU-IRB# 775/17-Nov-2024

Identifier Type: -

Identifier Source: org_study_id

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