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Endoscopic Versus Open Lumbar Discectomy in Diabetic Patients

A

Al-Azhar University

Status

Enrolling

Conditions

Diabetes Mellitus
Endoscope
Open
Lumbar Discectomy

Treatments

Procedure: Open lumbar discectomy
Procedure: Endoscopic lumbar discectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT07060846
DFM-IRB 00012367-25-06-009

Details and patient eligibility

About

This study aims to compare the endoscopic versus open lumbar discectomy in diabetic patients.

Full description

Diabetes mellitus (DM) is a highly prevalent disease with the capacity to adversely affect nearly every major organ system. DM has been demonstrated as a risk factor for a variety of complications within medical and surgical spheres Open lumbar discectomy is the most common surgical discectomy technique and is considered by many to be the gold standard.

Endoscopic lumbar discectomy allowed spinal surgeons to decompress a symptomatic lumbar nerve root by using an endoscopic minimally invasive surgical approach.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age from 18 to 75 years.
  • Both sexes.
  • Patients suffering from prolapsed lumbar disc postero-lateral, single level disc herniation at L4-5 or L5-S1 level with low back pain and unilateral radiculopathy and failure of conservative treatment for 12 weeks

Exclusion criteria

  • Extraforaminal disc herniation.
  • Recurrent and/or multiple level discs prolapses.
  • Spondylolisthesis.
  • Prior lumbar surgery at the same spinal level.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Group I
Experimental group
Description:
Patients will undergo endoscopic lumbar discectomy.
Treatment:
Procedure: Endoscopic lumbar discectomy
Group II
Active Comparator group
Description:
Patients will undergo an open lumbar discectomy.
Treatment:
Procedure: Open lumbar discectomy

Trial contacts and locations

1

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Central trial contact

Awad M Hegab, MD

Data sourced from clinicaltrials.gov

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