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

Tarlov Cysts Clinical Trial

— ARCSTSCC  

Official title:

A Randomized Controlled Study of Nerve Root Sleeve Reinforcement and Reconstruction and Sacral Canopy for the Treatment of Sacral Canal Cysts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04465305
• Other study ID #: PekingUTHNSD
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2020
• Source: Peking University Third Hospital
• Contact: liu bin
• Phone: 13671027688
• Email: liubin301[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Cysts
• Tarlov Cysts

Intervention

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

Locations

Country	Name	City	State
China	Peking University Third Hospital	Peking	Haidian

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrent rate of tarlov cysts	patents who recurrent postoperation	1 year