Comparison Between Conventional vs. Endoscopic Lumbar Discectomy

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137485
• Other study ID #: ENDODISC
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: August 2018

Study information

• Verified date: December 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniation

Intervention

Procedure:
• Conventional open lumbar discectomy
Removal of single level lumbar disc herniation through conventional discectomy.
• Percutaneous Endoscopic Translaminar lumbar discectomy.
Removal of single level Lumbar disc herniation using endoscope.

Device:
• Easy Go system Endoscopy
This system will be used to remove herniated disc in endoscopic group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

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. — View Citation

Gibson JN, Waddell G. Surgical interventions for lumbar disc prolapse. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD001350. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of Preoperative low back pain and radicular pain.	Improvement of preoperative low back pain and radicular pain.Clinical outcomes will be measured using Visual Analogue Scale.	Up to ten months post operative.
Primary	Functional Improvement	Functional Improvement using modified MacNab's criteria	Up to ten months post operative.
Secondary	Hospital stay.	Time spent in hospital post operative.	up to one week.
Secondary	Periprocedural complication.	Such as neurological deficit, Cerebro-Spinal fluid (CSF) leak, wound infection...etc.	Up to two weeks.
Secondary	Blood loss	Amount of blood loss intraoperative.	intraoperative.
Secondary	lumbo-sacral MRI	Demonstration of any disc herniation recurrence.	Up to six months
Secondary	Operative time	duration of operation	Intraoperative
Secondary	Wound length	Length of incision needed by surgeon to complete each approach	Intraoperative