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A Randomized Controlled Study on the Treatment of Sacral Canal Cysts With Sacral Canal Reinforcement (ARCSTSCC)

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ClinicalTrials.gov Identifier: NCT04465305
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : July 8, 2021
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Peking University Third Hospital

Brief Summary:
The subject will treat 68 patients with symptomatic sacral canal cysts as the research object, and adopt a randomized controlled research method, respectively, using two methods of reinforcement and reconstruction of the nerve root sleeve, sacroplasty and nerve root sleeve plasty, and observed the operation of the patient Complications, preoperative and postoperative short-term and long-term VAS pain scores, JOA neural function scores, and changes in cyst size on imaging examinations, to evaluate the safety of nerve root sleeve reconstruction and sacroplasty in reducing the safety of postoperative cyst recurrence Sex and effectiveness, so as to further improve the surgical treatment of sacral canal cysts, improve the curative effect, and formulate the operation specifications for the treatment of sacral canal cyst

Condition or disease Intervention/treatment Phase
Tarlov Cysts Procedure: entraped treatment Procedure: plasty treatment Not Applicable

Detailed Description:
In this subject, a cohort observation method was used to observe 52 patients with two types of surgical removal of hematoma in the basal ganglia under the guidance of frontal ultrasound through keyhole neuroendoscopy and microsurgery for hematoma removal under the guidance of frontal ultrasound. They were divided into endoscopic surgery group and microsurgery. In the endoscopic surgery group, 26 cases were treated with keyhole neuroendoscopy under the guidance of frontal ultrasound for hematoma removal in the basal ganglia area, and 26 cases in the microsurgery group were treated by craniotomy microsurgery hematoma removal surgery. Observe the removal rate of surgical hematoma in the two groups And the safety of the operation and the GCS score, GOS score and MRI examination of nerve fiber damage and postoperative complications at 1 week, 1 month, and 3 months after the operation. Observe and analyze the improvement of the hematoma clearance rate in the endoscopic surgery group. And whether it has an advantage in terms of efficacy

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Nerve Root Sleeve Reinforcement and Reconstruction and Sacral Canopy for the Treatment of Sacral Canal Cysts
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: enraped group
patients with a new treatment of tarlov cysts
Procedure: entraped treatment
patients with tarlov cysts treated by entraped and plasty nerve root
Other Name: plasty treatment

Procedure: plasty treatment
patients with tarlov cysts treated by plasty nerve root

Active Comparator: plasty group
patients with traditional treatment of tarlov cysts
Procedure: plasty treatment
patients with tarlov cysts treated by plasty nerve root




Primary Outcome Measures :
  1. recurrent rate of tarlov cysts [ Time Frame: 1 year ]
    patents who recurrent postoperation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Symptomatic nerve root cysts diagnosed by MRI
  2. Intact cyst capsule, no defect of sacral canal lamina
  3. No other diseases of nervous system, pelvic floor and important organs
  4. Agree inclusion

Exclusion Criteria:

a ) Non-radiculent cysts or asymptomatic cysts b) Cysts cause severe bone erosion to lamina resorption c) Combined with other diseases of nervous system, pelvic floor and important organs d) Disagree to join e) Cannot complete follow-up -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465305


Contacts
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Contact: liu bin 13671027688 liubin301@163.com
Contact: wu chao 82267358 ext 086010

Locations
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China, Haidian
Peking University Third Hospital Recruiting
Peking, Haidian, China, 100191
Contact: liu bin    13671027688    liubin301@163.com   
Sponsors and Collaborators
Peking University Third Hospital
Beijing Municipal Science & Technology Commission
Investigators
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Study Chair: liu bin Peking University Third Hospital
Study Director: wang zhenyu Peking University Third Hospital
Principal Investigator: xie jinchen Peking University Third Hospital
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04465305    
Other Study ID Numbers: PekingUTHNSD
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University Third Hospital:
tarlov cysts surgery
Additional relevant MeSH terms:
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Cysts
Tarlov Cysts
Neoplasms
Pathological Conditions, Anatomical
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases