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

Not Applicable

• Conditions: Tarlov Cysts
• Interventions: Procedure: entraped treatment; Procedure: plasty treatment

• Registration Number: NCT04465305
• Lead Sponsor: 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

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 Timeline

• Status Verified: 2020-07
• Study Start: 2020-07-01
• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-10
• Last Update Submitted: 2021-07-04
• Last Update Posted: 2021-07-08
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
enraped group	plasty treatment	patients with a new treatment of tarlov cysts
enraped group	entraped treatment	patients with a new treatment of tarlov cysts
plasty group	plasty treatment	patients with traditional treatment of tarlov cysts

Primary Outcome Measures

Name	Time	Method
recurrent rate of tarlov cysts	1 year	patents who recurrent postoperation

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Peking, Haidian, China