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Набор скоро начнётся NCT06756984

Long-Term Outcomes of Different Surgical Techniques for Sacral Tarlov Cysts: A Prospective Cohort Study

— Наблюдательное Sacral Tarlov Cysts Symptomatic Sacral Cysts Chronic Pain Related to Sacral Cysts Neurological Dysfunction Associated With Tarlov Cysts

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Partial Cyst Wall Resection with Nerve Root Sleeve Plasty, Partial Cyst Wall Resection with Nerve Root Sleeve Reinforcement and Reconstruction:, Autologous Fat/Muscle with Fibrin Glue Microscopic Cyst Filling.
Кому может быть актуально
Состояния в реестре: Sacral Tarlov Cysts, Symptomatic Sacral Cysts, Chronic Pain Related to Sacral Cysts, Neurological Dysfunction Associated With Tarlov Cysts. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
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Официальное название

A Prospective Cohort Study on the Long-Term Outcomes and Prognostic Factors of Different Surgical Techniques for the Treatment of Sacral Tarlov Cysts

Обзор

Brief Summary The goal of this observational study is to evaluate the long-term outcomes of different surgical techniques for sacral Tarlov cysts in adult patients aged 18-75 years diagnosed with symptomatic sacral Tarlov cysts. The main questions it aims to answer are: * Does one surgical technique result in better pain relief (measured by VAS score) and functional recovery (measured by JOA score) compared to others? * How do different surgical techniques impact the long-term recurrence rate and complication rate? Researchers will compare three surgical techniques: 1. Partial cyst wall resection with nerve root sleeve plasty. 2. Partial cyst wall resection with nerve root sleeve reinforcement and reconstruction. 3. Autologous fat/muscle with fibrin glue microscopic cyst filling. Participants will: * Undergo one of the three surgical procedures based on clinical indications. * Complete preoperative and postoperative assessments, including pain and functional scoring, as well as MRI evaluations at baseline and during follow-up. * Participate in a follow-up program for up to 2 years to monitor outcomes and recurrence.

Вмешательства

  • Процедура Partial Cyst Wall Resection with Nerve Root Sleeve Plasty
    Surgical technique involving partial removal of the cyst wall to decompress the nerve root, followed by plasty of the nerve root sleeve to restore nerve function and prevent recurrence.
  • Процедура Partial Cyst Wall Resection with Nerve Root Sleeve Reinforcement and Reconstruction:
    Advanced surgical technique combining partial cyst wall removal with additional reinforcement and reconstruction of the nerve root sleeve to provide enhanced support and reduce the risk of cyst recurrence.
  • Процедура Autologous Fat/Muscle with Fibrin Glue Microscopic Cyst Filling
    Minimally invasive surgical technique where autologous fat or muscle tissue is used to fill the cyst cavity, and fibrin glue is applied to seal the defect, aiming to obliterate the cyst and prevent cerebrospinal fluid leakage.

Первичные конечные точки

  • Pain Reduction Assessed by Visual Analog Scale (VAS) [Срок оценки: Baseline, 1 month, 3 months, 6 months, 12 months and 24 months postoperatively]
  • Neurological Function Improvement Assessed by Japanese Orthopedic Association (JOA) Score [Срок оценки: Baseline, 1 month, 3 months, 6 months, 12 months and 24 months postoperatively]
Вторичные конечные точки (1)
  • Recurrence Rate of Sacral Tarlov Cysts [Срок оценки: 12 months postoperatively and annually up to 2 years]

Критерии участия

Критерии включения

  • Age 18-75 years.
  • Diagnosed with symptomatic sacral Tarlov cysts confirmed by MRI.
  • Presence of at least one of the following symptoms:
  • Persistent sacral or lower back pain (VAS score ≥ 4).
  • Neurological deficits such as lower extremity numbness or weakness.
  • Bowel, bladder, or sexual dysfunction attributable to the cyst.
  • Eligible for surgical intervention based on clinical evaluation.
  • Willing and able to provide written informed consent.

Критерии исключения

  • History of prior sacral Tarlov cyst surgery.
  • Concurrent spinal conditions requiring separate surgical intervention.
  • Active infection or systemic inflammatory disease.
  • Severe comorbidities that increase surgical risk (e.g., advanced cardiac or pulmonary disease).
  • Pregnancy or lactation.
  • Inability to comply with follow-up requirements.
  • Known allergy or contraindication to surgical materials (e.g., fibrin glue).

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06756984 · STC_2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗