Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele

Официальное название

Conservative Versus Interventional Management of Postsurgical CSF Pseudomeningocele: A Randomized Controlled Trial

Обзор

Dear Sir or Madam, You have been invited to participate in a clinical study whose aim is to compare the effectiveness of two different approaches to the treatment of cerebrospinal fluid (CSF) pseudomeningocele - conservative management and interventional treatment (surgical or drainage procedures). CSF pseudomeningocele is a complication that may occur after brain surgery and is characterized by an accumulation of cerebrospinal fluid beneath the skin. At present, there is no clear consensus regarding the optimal treatment approach. How the study will be conducted After enrollment in the study, you will be randomly assigned (by chance) to one of two groups: Conservative management: no surgical intervention, regular follow-up, and wound care. Interventional treatment: simple aspiration/puncture, insertion of a lumbar drain, or reoperation. During the study, you will be followed for a period of 1 year. Follow-up examinations will include clinical assessment and brain imaging (CT or MRI) at 4 months and 12 months after enrollment. Risks associated with the interventional group Simple cyst aspiration/puncture: infection, bleeding into the pseudomeningocele. Lumbar drainage: infection, meningitis, bleeding at the insertion site, cerebrospinal fluid leakage, nerve root irritation, headaches. Reoperation: bleeding, infection, complications related to general anesthesia. Expected duration of participation in the study 12 months Expected total number of participants enrolled in the study 20 participants Benefit of the study The aim of the study is to compare the effect of surgical intervention with conservative management. Compensation for participation Participation in this study is not associated with any financial compensation.

Вмешательства

• Процедура Lumbar Drainage
  Insertion of Lumbar drain
• Процедура Pseudomeningocele Puncture
  aspiration of the CSF fluid with injection
• Процедура Puncture with Fibrin Glue Application
  after aspiration of the CSF a fibrin glue is injected into the pseudomeningocele
• Процедура Revision
  Revision surgery in order to prevent future pseudomeninogocele formation

Первичные конечные точки

• CSF Leakage or Tension pseudomeningocoele [Срок оценки: 12 months]

Вторичные конечные точки (4)

• Infection [Срок оценки: 12 months]
• Glasgow Outcome Scale Extended (GOSE) [Срок оценки: 12 months]
• Absorption of the Pseudomeningocoele [Срок оценки: 12 months]
• Pain [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Pseudomeningocele after elective intracranial surgery
• Willing and able to give informed consent
• No prior cranial or spinal surgical intervention
• Pseudomeningocele Palpation Scale (PPS) II-IV, no severe pain of the PMC (VAS 7-10) - Tension MK

Критерии исключения

• PMC following emergency or trauma surgery
• Known or suspected infection at the PMC site at recruitment
• Severe comorbidities preventing participation (e.g. terminal illness, organ failure)
• Conditions requiring urgent unrelated surgical intervention

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Чехия · 1 центр

• Military University Hospital Prague — Prague

Идентификаторы

NCT: NCT07614399 · 108/20-55/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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