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临床试验/NCT03137485
NCT03137485已完成不适用

Management of Lumbar Postero-lateral Single Level Disc Herniation: Comparative Study Between Conventional and Endoscopic Lumbar Discectomy

Assiut University0 个研究点目标入组 30 人开始时间: 2016年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
主要终点
Functional Improvement

研究概览

简要总结

This study is aimed to compare between the results of conventional lumbar discectomy and the newly used technique in our department; endoscopic lumbar discectomy in neurosurgery department Assiut university hospitals, so that we can offer our patients the best service in an updated and minimally invasive way.

详细描述

Lumbar discectomy is one of the most common operation performed worldwide for lumbar-related symptoms. Lumbar disc herniation accounts for only 5% of all low back pain problems but is the most common cause of radiating nerve root pain, sciatica.

Mixter and Barr described the first surgical procedure to remove the herniated lumbar disc in 1934 through a laminectomy and durotomy, with later enhancement by Semmes, who described approaching the herniated disc through hemilaminectomy and retraction of the dural sac. This became popularized as the "classical discectomy technique.

During the latter half of the 19th century, more techniques were developed to remove the herniated disc with minimal invasiveness. The first herniated disc excision using a microscope (microdiscectomy) was performed by Yasargil in 1977, which was the standard surgical procedure at the time In 1993, Mayer and Brock and then in 1997, Smith and Foley described endoscopic discectomy techniques. With these minimally invasive techniques, authors demonstrated decreased soft tissue manipulation, operative time, blood loss, and hospital stay, allowing early recovery.

In this study we try to evaluate clinical and radiological outcomes of percutaneous endoscopic translaminar discectomy at our hospital.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • single level, postero-lateral, denovo lumbar disc herniation including those with migrated and/or sequestrated discs.
  • L4,5 &L5,S1 disc prolapse
  • Failure of conservative management after 12 weeks.

排除标准

  • central, far lateral, recurrent and/or multiple level disc herniation.
  • Lateral recess stenosis or spondylolisthesis.
  • presence of neurological deficit.

研究组 & 干预措施

Conventional

Active Comparator

Patients in this arm will have conventional open lumbar discectomy operation.

干预措施: Conventional open lumbar discectomy (Procedure)

Endoscopic

Active Comparator

Patients in this arm will have Percutaneous Endoscopic Translaminar lumbar discectomy operation using Easy Go system Endoscopy

干预措施: Percutaneous Endoscopic Translaminar lumbar discectomy. (Procedure)

Endoscopic

Active Comparator

Patients in this arm will have Percutaneous Endoscopic Translaminar lumbar discectomy operation using Easy Go system Endoscopy

干预措施: Easy Go system Endoscopy (Device)

结局指标

主要结局

Functional Improvement

时间窗: Up to ten months post operative.

Functional Improvement using modified MacNab's criteria

Improvement of Preoperative low back pain and radicular pain.

时间窗: Up to ten months post operative.

Improvement of preoperative low back pain and radicular pain.Clinical outcomes will be measured using Visual Analogue Scale.

次要结局

  • Hospital stay.(up to one week.)
  • Blood loss(intraoperative.)
  • lumbo-sacral MRI(Up to six months)
  • Wound length(Intraoperative)
  • Operative time(Intraoperative)
  • Periprocedural complication.(Up to two weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

H A Othman

Resident Doctor, Neurosurgery Department, Assiut Universiy Hosipitals

Assiut University

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