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NCT Number: NCT07060781

Management of Seroma After Posterior Lumbar Spine Decompression

The aim of this study is to evaluate the clinical presentation and management strategies of seroma formation following posterior lumbar spine decompression.

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Key information

Conditions

Seroma Inflammation Lumbar Spine Decompression Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location status: Recruiting

Location contact

Ahmed A Zahra, MD

PRINCIPAL_INVESTIGATOR

Ayman M Basha, MD

CONTACT

[email protected]

00201063037278

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Posterior Lumbar Spine Decompression

Procedure

Patients undergoing elective posterior lumbar spine decompression.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of aspirations required

    Time frame: 6 months postoperatively

    Number of aspirations required will be recorded.

  2. Seroma recurrence rate

    Time frame: 6 months postoperatively

    Seroma recurrence rate will be recorded.

  3. Association with patient risk factor

    Time frame: 6 months postoperatively

    Association with patient risk factor will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayman M Basha, MD

CONTACT

[email protected]

00201063037278

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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