Traumatic Injury of Spleen:Laparoscopic Splenectomy Vs Splenic Artery Embolization

December 8, 2025 updated by: Zagazig University

Management of Grade III Traumatic Splenic Injury in Hemodynamically Stable Patients ; Laparoscopic Splenectomy Versus Splenic Artery Embolization by Interventional Radiology

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Zagazig university,Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laparoscopic Splenectomy
Procedure: 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
Active Comparator: Splenic Artery Embolization
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with clinical complications: as pain, fever, leucocytosis, vomiting, or illeus.
Time Frame: 6 months
Number of participants with clinical complications: like Pain, fever, leucocytosis, vomiting, or illeus.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery time: Length of postoperative hospital stay in days.
Time Frame: 6 months.
Recovery time: Length of postoperative hospital stay in days.
6 months.
Measuring post operative pain severity using pain severity score.
Time Frame: 6 months.
Measuring post operative pain severity using pain severity score. Minimum score =1. Maximum score= 10. The lower the score the better the outcome.
6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Actual)

May 31, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

October 1, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ZU-IRB# 775/17-Nov-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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