Clinical trial NCT03137485: Comparison Between Conventional vs. Endoscopic Lumbar Discectomy
Official title: Management of Lumbar Postero-lateral Single Level Disc Herniation: Comparative Study Between Conventional and Endoscopic Lumbar Discectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: lumbar disc herniation
endoscopic discectomy
open discectomy
comparative study
Translaminar
surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Improvement of Preoperative low back pain and radicular pain.
timeFrame: Up to ten months post operative.
measure: Functional Improvement
timeFrame: Up to ten months post operative.
Secondary outcomes:
measure: Hospital stay.
timeFrame: up to one week.
measure: Periprocedural complication.
timeFrame: Up to two weeks.
measure: Blood loss
timeFrame: intraoperative.
measure: lumbo-sacral MRI
timeFrame: Up to six months
measure: Operative time
timeFrame: Intraoperative
measure: Wound length
timeFrame: Intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Head of Neurosurgery Department, Assiut University Hospitals
name: Mohammad T Ahmed, Professor
role: STUDY_CHAIR
References:
citation: Gibson JN, Waddell G. Surgical interventions for lumbar disc prolapse. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD001350. doi: 10.1002/14651858.CD001350.pub4.
citation: Gotfryd A, Avanzi O. A systematic review of randomised clinical trials using posterior discectomy to treat lumbar disc herniations. Int Orthop. 2009 Feb;33(1):11-7. doi: 10.1007/s00264-008-0559-2. Epub 2008 May 24.
citation: Evaniew N, Khan M, Drew B, Kwok D, Bhandari M, Ghert M. Minimally invasive versus open surgery for cervical and lumbar discectomy: a systematic review and meta-analysis. CMAJ Open. 2014 Oct 1;2(4):E295-305. doi: 10.9778/cmajo.20140048. eCollection 2014 Oct.
citation: Jiang W, Sun B, Sheng Q, Song X, Zheng Y, Wang L. Feasibility and efficacy of percutaneous lateral lumbar discectomy in the treatment of patients with lumbar disc herniation: a preliminary experience. Biomed Res Int. 2015;2015:378612. doi: 10.1155/2015/378612. Epub 2015 Jan 28.