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Recruiting NCT07060846

Endoscopic Versus Open Lumbar Discectomy in Diabetic Patients

No phase Interventional Endoscope Open Lumbar Discectomy Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic lumbar discectomy, Open lumbar discectomy.
Who it may be relevant to
Registry conditions: Endoscope, Open, Lumbar Discectomy, Diabetes Mellitus. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Endoscopic Versus Open Lumbar Discectomy in Diabetic Patients: A Randomized Controlled Trial

Overview

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

Detailed 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.

Interventions

  • Procedure Endoscopic lumbar discectomy
    Patients will undergo endoscopic lumbar discectomy.
  • Procedure Open lumbar discectomy
    Patients will undergo an open lumbar discectomy.

Primary outcome measures

  • Degree of low back pain [Time frame: 48 hours postoperatively]
Secondary outcome measures (5)
  • Degree of radicular pain [Time frame: 48 hours postoperatively]
  • Length of hospital stay [Time frame: 1 week postoperatively]
  • Intraoperative blood loss [Time frame: Intraoperatively]
  • Operative time [Time frame: Intraoperatively]
  • Wound length [Time frame: Intraoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Al-Azhar University (Damietta) — Damietta

Identifiers

NCT: NCT07060846 · DFM-IRB 00012367-25-06-009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗