Grade III Traumatic Splenic Injury in Hemodynamically Stable PatientsNCT07274007
Traumatic Injury of Spleen:Laparoscopic Splenectomy Vs Splenic Artery Embolization
A study testing Laparoscopic Splenectomy vs splenic Artery Embolization in people with Grade III Traumatic Splenic Injury in Hemodynamically Stable Patients, run by Zagazig University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Grade III Traumatic Splenic Injury in Hemodynamically Stable Patients
- What is being tested?
- Laparoscopic Splenectomy vs splenic Artery Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients aged above 12 years at time of screening.
- Patients diagnosed with grade three traumatic Splenic Injury
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Assess the quality of life and clinical outcome after using laparoscopic Splenectomy in management of grade 3 traumatic Splenic Injury in Hemodynamically Stable Patients
- 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
Read more
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
- Being tested
- Laparoscopic Splenectomy vs splenic Artery Embolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Splenectomy vs splenic Artery EmbolizationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Splenectomy | Active comparator | Not described Receives: Procedure: Laparoscopic Splenectomy vs splenic Artery Embolization |
| Splenic Artery Embolization | Active comparator | Not described Receives: Procedure: Laparoscopic Splenectomy vs splenic Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinical complications: as pain, fever, leucocytosis, vomiting, or illeus.
Number of participants with clinical complications: like Pain, fever, leucocytosis, vomiting, or illeus.
Measured: 6 months
Secondary outcomes (2)
Recovery time: Length of postoperative hospital stay in days.
Recovery time: Length of postoperative hospital stay in days.
Measured: 6 months.
Measuring post operative pain severity using pain severity score.
Measuring post operative pain severity using pain severity score. Minimum score =1. Maximum score= 10. The lower the score the better the outcome.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Dec 2024
- Primary completion31 May 2025
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade III Traumatic Splenic Injury in Hemodynamically Stable PatientsStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274007
- Sponsor's protocol ID
- ZU-IRB# 775/17-Nov-2024
- Status last verified
- Dec 2025
- First submitted
- 1 Oct 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Grade III Traumatic Splenic Injury in Hemodynamically Stable Patients ; Laparoscopic Splenectomy Versus Splenic Artery Embolization by Interventional Radiology
- ClinicalTrials.gov ID
- NCT07274007
- Acronym / sponsor ID
- ZU-IRB# 775/17-Nov-2024
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Assess the quality of life and clinical outcome after using laparoscopic Splenectomy in management of grade 3 traumatic Splenic Injury in Hemodynamically Stable Patients
- 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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Splenectomy | Active comparator | Procedure: Laparoscopic Splenectomy vs splenic Artery Embolization |
| Splenic Artery Embolization | Active comparator | Procedure: Laparoscopic Splenectomy vs splenic Artery Embolization |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged above 12 years at time of screening.
- Patients diagnosed with grade three traumatic Splenic Injury
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Splenectomy vs splenic Artery EmbolizationCompare 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 | Procedure or surgery | Laparoscopic Splenectomy, Splenic Artery Embolization |
Primary outcome
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.
2 secondary outcomes
Recovery time: Length of postoperative hospital stay in days.
Time frame: 6 months.
Measuring post operative pain severity using pain severity score.
Time frame: 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Splenectomy vs splenic Artery Embolization in people with Grade III Traumatic Splenic Injury in Hemodynamically Stable Patients, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with clinical complications: as pain, fever, leucocytosis, vomiting, or illeus. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.