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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04465305
Collaborator
Beijing Municipal Science & Technology Commission (Other)
68
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: entraped treatment
  • Procedure: plasty treatment
 N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Jul 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. recurrent rate of tarlov cysts [1 year]

      patents who recurrent postoperation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Third Hospital Peking Haidian China 100191

    Sponsors and Collaborators

    • Peking University Third Hospital
    • Beijing Municipal Science & Technology Commission

    Investigators

    • Study Chair: liu bin, Peking University Third Hospital
    • Study Director: wang zhenyu, Peking University Third Hospital
    • Principal Investigator: xie jinchen, Peking University Third Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT04465305
    Other Study ID Numbers:
    • PekingUTHNSD
    First Posted:
    Jul 10, 2020
    Last Update Posted:
    Jul 8, 2021
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Cysts
    Tarlov Cysts

    Study Results

    No Results Posted as of Jul 8, 2021