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

NCT ID: NCT04465305

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-06-30

Brief Summary

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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

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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

Conditions

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Tarlov Cysts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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enraped group

patients with a new treatment of tarlov cysts

Group Type EXPERIMENTAL

entraped treatment

Intervention Type PROCEDURE

patients with tarlov cysts treated by entraped and plasty nerve root

plasty treatment

Intervention Type PROCEDURE

patients with tarlov cysts treated by plasty nerve root

plasty group

patients with traditional treatment of tarlov cysts

Group Type ACTIVE_COMPARATOR

plasty treatment

Intervention Type PROCEDURE

patients with tarlov cysts treated by plasty nerve root

Interventions

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entraped treatment

patients with tarlov cysts treated by entraped and plasty nerve root

Intervention Type PROCEDURE

plasty treatment

patients with tarlov cysts treated by plasty nerve root

Intervention Type PROCEDURE

Other Intervention Names

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plasty treatment

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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liu bin

Role: STUDY_CHAIR

Peking University Third Hospital

wang zhenyu

Role: STUDY_DIRECTOR

Peking University Third Hospital

xie jinchen

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, Haidian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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liu bin

Role: CONTACT

13671027688

wu chao

Role: CONTACT

82267358 ext. 086010

Facility Contacts

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liu bin

Role: primary

13671027688

Other Identifiers

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PekingUTHNSD

Identifier Type: -

Identifier Source: org_study_id

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