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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

Tracking Information
First Submitted Date  ICMJE July 6, 2020
First Posted Date  ICMJE July 10, 2020
Last Update Posted Date July 8, 2021
Actual Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2020)
recurrent rate of tarlov cysts [ Time Frame: 1 year ]
patents who recurrent postoperation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Study on the Treatment of Sacral Canal Cysts With Sacral Canal Reinforcement
Official Title  ICMJE A Randomized Controlled Study of Nerve Root Sleeve Reinforcement and Reconstruction and Sacral Canopy for the Treatment of Sacral Canal Cysts
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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tarlov Cysts
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: enraped group
    patients with a new treatment of tarlov cysts
    Interventions:
    • Procedure: entraped treatment
    • Procedure: plasty treatment
  • Active Comparator: plasty group
    patients with traditional treatment of tarlov cysts
    Intervention: Procedure: plasty treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2020)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: liu bin 13671027688 liubin301@163.com
Contact: wu chao 82267358 ext 086010
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04465305
Other Study ID Numbers  ICMJE PekingUTHNSD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peking University Third Hospital
Study Sponsor  ICMJE Peking University Third Hospital
Collaborators  ICMJE Beijing Municipal Science & Technology Commission
Investigators  ICMJE
Study Chair: liu bin Peking University Third Hospital
Study Director: wang zhenyu Peking University Third Hospital
Principal Investigator: xie jinchen Peking University Third Hospital
PRS Account Peking University Third Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP