An observational study in Seroma and Lumbar Spine Decompression, sponsored by Kafrelsheikh University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by Kafrelsheikh University · Observational
The aim of this study is to evaluate the clinical presentation and management strategies of seroma formation following posterior lumbar spine decompression.
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.
101 studies on the registry are indexed under Seroma; 22 are open to participants now.
Browse Seroma studies →Kafrelsheikh University is the lead sponsor of 294 studies on the registry; 114 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing elective posterior lumbar spine decompression.
Procedure: Posterior Lumbar Spine Decompression
Patients undergoing elective posterior lumbar spine decompression.
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.
Time frame: 6 months postoperatively
Number of aspirations required
Number of aspirations required will be recorded.
Time frame: 6 months postoperatively
Seroma recurrence rate
Seroma recurrence rate will be recorded.
Time frame: 6 months postoperatively
Association with patient risk factor
Association with patient risk factor will be recorded.
Time frame: 6 months postoperatively
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
Time frame: After the end of study for one year.
Access criteria: The data will be available upon a reasonable request from the corresponding author.
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