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Study on Pathogenesis and Treatment of Sacral Tarlov Cysts

Primary Purpose

Tarlov Cysts

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
modified ostium obstruction surgery
Sponsored by
Southern Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tarlov Cysts focused on measuring Sacral perineural cyst, Tarlov cyst, Ostium closure, Surgical treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Neurosurgery department, Nanfang HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Modified operation group

Arm Description

Undergo the modified ostium obstruction surgery due to symptomatic TCs.

Outcomes

Primary Outcome Measures

The visual analogue scale (VAS)
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
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)
Maximum diameter of TCs.
Histological examination results
Part of the intact cyst wall was stained with Sirius red and its anatomical membranous layers were observed under a microscope.

Secondary Outcome Measures

Surgical characteristics
Operative process
Clinical manifestations
Symptoms and their features
Demographic data
Age

Full Information

First Posted
September 11, 2021
Last Updated
September 20, 2021
Sponsor
Southern Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT05059275
Brief Title
Study on Pathogenesis and Treatment of Sacral Tarlov Cysts
Official Title
Study on Pathogenesis and Treatment of Sacral Tarlov Cysts
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tarlov Cysts
Keywords
Sacral perineural cyst, Tarlov cyst, Ostium closure, Surgical treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified operation group
Arm Type
Experimental
Arm Description
Undergo the modified ostium obstruction surgery due to symptomatic TCs.
Intervention Type
Procedure
Intervention Name(s)
modified ostium obstruction surgery
Intervention Description
An ostium at the end of the site where the nerve root enters the dural sac, from which CSF could flow continuously along the subarachnoid space, was identified An appropriate amount of autologous soft adipose tissue was removed under the skin of the incision or deep in the upper part of the buttock (Iliac spine incision, for less subcutaneous fat patients). It was then trimmed to resemble a gourd or dumbbell, with a relatively small middle section and two relatively large end sections. Trimmed graft was inserted into the neck of the sac and subarachnoid space below the dural sac so that it plugs the ostium inside and outside After filling the graft, Prolene 6-0 was used to continuously suture and close the ostium and dural sac starting from the lower part of the nerve root sheath and the ostium.The residual cyst cavity filled with autologous fat and gelatin sponge
Primary Outcome Measure Information:
Title
The visual analogue scale (VAS)
Description
The visual analogue scale (VAS),Score range: 0-10, with a higher score indicating more severe pain
Time Frame
Three months after surgery
Title
Scoring System for the Clinical Evaluation of Patients with Spinal Processes
Description
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.
Time Frame
One year after surgery
Title
Evaluation of imaging results (magnetic resonance and computerized tomography)
Description
Maximum diameter of TCs.
Time Frame
One days before surgery
Title
Histological examination results
Description
Part of the intact cyst wall was stained with Sirius red and its anatomical membranous layers were observed under a microscope.
Time Frame
One day after surgery
Secondary Outcome Measure Information:
Title
Surgical characteristics
Description
Operative process
Time Frame
During surgery
Title
Clinical manifestations
Description
Symptoms and their features
Time Frame
Two days before surgery
Title
Demographic data
Description
Age
Time Frame
Three days before surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qinguo Huang, M.D.
Phone
13642207060
Ext
+86
Email
hqghcjr0920@126.com
Facility Information:
Facility Name
Neurosurgery department, Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinguo Huang, M.D.
Phone
13642207060
Ext
+86
Email
hqghcjr0920@126.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
From the completion of data collection to 1 month after the publication of the article
Citations:
PubMed Identifier
30738394
Citation
Sharma M, SirDeshpande P, Ugiliweneza B, Dietz N, Boakye M. A systematic comparative outcome analysis of surgical versus percutaneous techniques in the management of symptomatic sacral perineural (Tarlov) cysts: a meta-analysis. J Neurosurg Spine. 2019 Feb 8:1-12. doi: 10.3171/2018.10.SPINE18952. Online ahead of print.
Results Reference
background
PubMed Identifier
19569467
Citation
Singh PK, Singh VK, Azam A, Gupta S. Tarlov cyst and infertility. J Spinal Cord Med. 2009;32(2):191-7. doi: 10.1080/10790268.2009.11760771.
Results Reference
background
PubMed Identifier
31270612
Citation
Fletcher-Sandersjoo A, Mirza S, Burstrom G, Pedersen K, Kuntze Soderqvist A, Grane P, Fagerlund M, Edstrom E, Elmi-Terander A. Management of perineural (Tarlov) cysts: a population-based cohort study and algorithm for the selection of surgical candidates. Acta Neurochir (Wien). 2019 Sep;161(9):1909-1915. doi: 10.1007/s00701-019-04000-5. Epub 2019 Jul 3.
Results Reference
background
PubMed Identifier
30544388
Citation
Liu B, Wang Z, Lin G, Zhang J. Radiculoplasty with reconstruction using 3D-printed artificial dura mater for the treatment of symptomatic sacral canal cysts: Two case reports. Medicine (Baltimore). 2018 Dec;97(49):e13289. doi: 10.1097/MD.0000000000013289.
Results Reference
background
PubMed Identifier
17538380
Citation
Guo D, Shu K, Chen R, Ke C, Zhu Y, Lei T. Microsurgical treatment of symptomatic sacral perineurial cysts. Neurosurgery. 2007 Jun;60(6):1059-65; discussion 1065-6. doi: 10.1227/01.NEU.0000255457.12978.78.
Results Reference
background
PubMed Identifier
13385699
Citation
ABBOTT KH, LEIMBACH WH, RETTER RH. The role of perineurial sacral cysts in the sciatic and sacrococcygeal syndromes; a review of the literature and report of 9 cases. J Neurosurg. 1957 Jan;14(1):5-21. doi: 10.3171/jns.1957.14.1.0005. No abstract available.
Results Reference
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Study on Pathogenesis and Treatment of Sacral Tarlov Cysts

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