SeromaNCT07060781
Management of Seroma After Posterior Lumbar Spine Decompression
An observational study of Seroma and Lumbar Spine Decompression, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the clinical presentation and management strategies of seroma formation following posterior lumbar spine decompression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seroma, Lumbar Spine Decompression
- What is being tested?
- Posterior Lumbar Spine Decompression
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jul 2025to 30 Dec 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study will be conducted on 50 adult patients undergoing posterior lumbar spine decompression surgery at Kafr Elsheikh University Hospitals. Approval from the Medical Sciences Ethics Committee of Kafr Elsheikh Faculty of Medicine will be taken. Written informed consent will be obtained from all participants before enrollment.
Who may be able to join
- Age ≥ 18 years.
- Both sexes.
- Patients undergoing elective posterior lumbar spine decompression.
Who cannot join
- History of previous lumbar spine surgery.
- Active spinal infection, trauma, or malignancy.
- Severe medical comorbidities that contraindicate surgery or influence wound healing (e.g., uncontrolled diabetes, immunosuppression, severe cardiovascular disease).
- Patients unfit for general anesthesia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 33516
Ayman M Basha, MD, 00201063037278, aymanbasha424@gmail.com
Ahmed A Zahra, MD
About this study
The aim of this study is to evaluate the clinical presentation and management strategies of seroma formation following posterior lumbar spine decompression.
Read the detailed description
Posterior lumbar spine decompression is a widely employed surgical approach to alleviate neural element compression due to degenerative spinal conditions such as spinal stenosis, spondylolisthesis, and disc herniation. While generally effective in reducing symptoms and improving quality of life, this procedure is not without risk.
Seroma formation, in particular, may follow posterior decompressive surgery or fusion and is thought to arise from the accumulation of lymphatic or serous fluid in the dead space created by tissue dissection.
- Conditions
- Seroma, Lumbar Spine Decompression
- Being tested
- Posterior Lumbar Spine Decompression
- Medical subject headings
- Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Lumbar Spine DecompressionProcedure or surgery
Patients undergoing elective posterior lumbar spine decompression.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients undergoing elective posterior lumbar spine decompression. Receives: Procedure: Posterior Lumbar Spine Decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of seroma
Incidence of seroma formation following posterior lumbar spine decompression will be recorded during hospitalization and at scheduled postoperative follow-up visits at 2 weeks, 6 weeks, 3 months, and 6 months.
Measured: 6 months postoperatively
Secondary outcomes (3)
Number of aspirations required
Number of aspirations required will be recorded.
Measured: 6 months postoperatively
Seroma recurrence rate
Seroma recurrence rate will be recorded.
Measured: 6 months postoperatively
Association with patient risk factor
Association with patient risk factor will be recorded.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start19 Jul 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeromaStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Mohamed Basha, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060781
- Sponsor's protocol ID
- KFSIRB200-645
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Seroma After Posterior Lumbar Spine Decompression
- ClinicalTrials.gov ID
- NCT07060781
- Acronym / sponsor ID
- KFSIRB200-645
- Conditions
- Seroma, Lumbar Spine Decompression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 19 Jul 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 11 Jul 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 aim of this study is to evaluate the clinical presentation and management strategies of seroma formation following posterior lumbar spine decompression.
Detailed description
Posterior lumbar spine decompression is a widely employed surgical approach to alleviate neural element compression due to degenerative spinal conditions such as spinal stenosis, spondylolisthesis, and disc herniation. While generally effective in reducing symptoms and improving quality of life, this procedure is not without risk.
Seroma formation, in particular, may follow posterior decompressive surgery or fusion and is thought to arise from the accumulation of lymphatic or serous fluid in the dead space created by tissue dissection.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Posterior Lumbar Spine DecompressionPatients undergoing elective posterior lumbar spine decompression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study will be conducted on 50 adult patients undergoing posterior lumbar spine decompression surgery at Kafr Elsheikh University Hospitals. Approval from the Medical Sciences Ethics Committee of Kafr Elsheikh Faculty of Medicine will be taken. Written informed consent will be obtained from all participants before enrollment.
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Both sexes.
- Patients undergoing elective posterior lumbar spine decompression.
Key exclusion criteria (4 listed)
- History of previous lumbar spine surgery.
- Active spinal infection, trauma, or malignancy.
- Severe medical comorbidities that contraindicate surgery or influence wound healing (e.g., uncontrolled diabetes, immunosuppression, severe cardiovascular disease).
- Patients unfit for general anesthesia.
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 |
|---|---|---|
| Posterior Lumbar Spine DecompressionPatients undergoing elective posterior lumbar spine decompression. | Procedure or surgery | Study group |
Primary outcome
Incidence of seroma
Time frame: 6 months postoperatively
Incidence of seroma formation following posterior lumbar spine decompression will be recorded during hospitalization and at scheduled postoperative follow-up visits at 2 weeks, 6 weeks, 3 months, and 6 months.
3 secondary outcomes
Number of aspirations required
Time frame: 6 months postoperatively
Seroma recurrence rate
Time frame: 6 months postoperatively
Association with patient risk factor
Time frame: 6 months postoperatively
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 22 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seroma and Lumbar Spine Decompression, run by Kafrelsheikh 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 3 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: looking for participants now, as of the sponsor's last update on 22 Jul 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?
Contact Ayman M Basha, MD (00201063037278, aymanbasha424@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of seroma (time frame: 6 months postoperatively). 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 22 Jul 2025.