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临床试验/NCT07060781
NCT07060781招募中不适用

Management of Seroma After Posterior Lumbar Spine Decompression

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月19日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Incidence of seroma

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Incidence of seroma

时间窗: 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.

次要结局

  • Number of aspirations required(6 months postoperatively)
  • Seroma recurrence rate(6 months postoperatively)
  • Association with patient risk factor(6 months postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayman Mohamed Basha

Lecturer of Neurosurgery, Faculty of Medicine, KafrElsheikh University, KafrElsheikh, Egypt

Kafrelsheikh University

研究点 (1)

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