Management of Seroma After Posterior Lumbar Spine Decompression

Not yet recruiting

• Conditions: Seroma; Lumbar Spine Decompression

• Registration Number: NCT07060781
• Lead Sponsor: Kafrelsheikh University

Brief Summary

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 Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11
• Study Start: 2025-07-15
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age ≥ 18 years.
• Both sexes.
• Patients undergoing elective posterior lumbar spine decompression.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of seroma	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.

Secondary Outcome Measures

Name	Time	Method
Number of aspirations required	6 months postoperatively	Number of aspirations required will be recorded.
Seroma recurrence rate	6 months postoperatively	Seroma recurrence rate will be recorded.
Association with patient risk factor	6 months postoperatively	Association with patient risk factor will be recorded.

Trial Locations

Locations (1)

Kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Kafrelsheikh, Egypt