Clinical trial NCT04465305: A Randomized Controlled Study on the Treatment of Sacral Canal Cysts With Sacral Canal Reinforcement
Official title: A Randomized Controlled Study of Nerve Root Sleeve Reinforcement and Reconstruction and Sacral Canopy for the Treatment of Sacral Canal Cysts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tarlov Cysts
Keywords: tarlov cysts surgery
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2020-07-10
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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 -

Primary outcomes:
measure: recurrent rate of tarlov cysts
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University Third Hospital
state: Haidian
Study officials:
affiliation: Peking University Third Hospital
name: liu bin
role: STUDY_CHAIR
affiliation: Peking University Third Hospital
name: wang zhenyu
role: STUDY_DIRECTOR
affiliation: Peking University Third Hospital
name: xie jinchen
role: PRINCIPAL_INVESTIGATOR
References: