跳至主要内容
临床试验/NCT05059275
NCT05059275已完成不适用

Study on Pathogenesis and Treatment of Sacral Tarlov Cysts

Southern Medical University, China1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Histological examination results

研究概览

简要总结

The pathogenesis of sacral Tarlov cysts (TCs) is still unclear. In this study, histological techniques were used to clarify the anatomical membranous layers of TCs and further explore the pathogenesis of them.Although many approaches have been used to treat TCs, there is no consensus on the optimal treatment. Microsurgery is now increasingly recommended as the preferred treatment with the best long-term outcomes.However, some authors have proposed the opposite view because current microsurgical techniques fail to completely close the ostium between the cyst and subarachnoid space.Consequently, could lead to leakage of cerebrospinal fluid, pseudomeningocele , or a high frequency of cysts recurrence, which are the main reasons for surgical failure and also the biggest scruple when microsurgery is chosen. Herein, we present a new method of cyst separation and ostium closure, and evaluate its clinical reliability and effectiveness for surgical treatment of Tarlov cysts through the prospective study.

详细描述

  1. Part of the intact cyst wall was removed under the microscope and fixed in 10% formalin solution. After dehydration and paraffin embedding, tissue sections (thickness: 6μm) were prepared and dewaxed to water. Sirius red stain drops were stained for 1 hour. The staining liquid on the surface of the slices was removed after a little flushing with water. The slices were dehydrated and transparent, sealed with neutral gum, and the membranous layers of the capsule walls were observed under a microscope.It has been observed in previous surgeries that all cysts were incompressible and remained filled after opening the distal wall of the cyst to release cerebrospinal fluid(CSF). These findings lent support for the proposed valve mechanism as the etiology of the entity becoming symptomatic. In this study, the cyst was observed in the following way: the dural sac was opened to expose the ostium to observe whether the cystic fluid would reverse outflow and shrink the cyst; In this way, the existence of a "one-way valve" can be further verified.
  2. Modified microsurgical method is used to treat patients who met the inclusion criteria. To evaluate the surgical effect, we record and statistically compare the patients'outcomes before surgery and at the postoperative follow-up, which include the following: 1) Demographic data: sex, age, height, weight, body mass index (BMI), etc.; 2) clinical manifestations: symptoms and their features, complications, and long-term recovery; 3) Imaging findings: maximum diameter, location, shape, number, intracapsular nerve root condition, and postoperative outcome of TCs. 4) Surgical characteristics: operative process and time, intraoperative blood loss, assistive technologies, etc.; 5) Neurologic assessment using the following tools: The visual analogue scale (VAS), Scoring System for the Clinical Evaluation of Patients with Spinal Processes (hereinafter referred to as SCPS), Oswestry Disability Index (ODI), Japanese Orthopedic Association Scores 29 (JOA), and modified evaluation criteria for the efficacy of lumbar function (MacNab).All patients are required to return for MRI review and neurofunctional assessment at 3 and 12 months postoperatively, followed by annual examinations thereafter.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Conform to the surgical indications and undergo modified microscopic surgery in our department;
  • Undergo regular review and long-term clinical effect evaluation;
  • Agree to participate in this study.

排除标准

  • Ineligible for modified microscopic surgery or unwilling to undergo it;
  • Failure to cooperate with follow-up work or lost to follow-up;
  • Did not agree to participate in the study.

结局指标

主要结局

Histological examination results

时间窗: One day after surgery

Part of the intact cyst wall was stained with Sirius red and its anatomical membranous layers were observed under a microscope.

The visual analogue scale (VAS)

时间窗: Three months after surgery

The visual analogue scale (VAS),Score range: 0-10, with a higher score indicating more severe pain

Scoring System for the Clinical Evaluation of Patients with Spinal Processes

时间窗: One year after surgery

Scoring System for the Clinical Evaluation of Patients with Spinal Processes (hereinafter referred to as SCPS),score range:0- 25.The higher the score, the better the spinal cord function state.

Evaluation of imaging results (magnetic resonance and computerized tomography)

时间窗: One days before surgery

Maximum diameter of TCs.

次要结局

  • Demographic data(Three days before surgery)
  • Surgical characteristics(During surgery)
  • Clinical manifestations(Two days before surgery)

研究者

发起方
Southern Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuntao Lu

Professor

Southern Medical University, China

研究点 (1)

Loading locations...

相似试验