Health TrialsbyHealthPanel

Endoscopic Versus Open Lumbar Discectomy in Diabetic Patients

ConditionsEndoscopeOpenLumbar DiscectomyDiabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAl-Azhar University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Extraforaminal disc herniation.

Recurrent and/or multiple level discs prolapses.

Spondylolisthesis.

Prior lumbar surgery at the same spinal level.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endoscopic lumbar discectomy

    Procedure/Surgery

    Patients will undergo endoscopic lumbar discectomy.

  • Open lumbar discectomy

    Procedure/Surgery

    Patients will undergo an open lumbar discectomy.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group IExperimental treatment 1 intervention
Group B: Group IIActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Degree of low back pain

The patients will be evaluated clinically using Visual Analogue Score (VAS) for low back pain and radicular pain. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.

Time frame
48 hours postoperatively

Secondary outcomes

1

Degree of radicular pain

The patients will be evaluated clinically using Visual Analogue Score (VAS) for radicular pain and radicular pain. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.

Time frame
48 hours postoperatively
2

Length of hospital stay

Length of hospital stay will be recorded from admission till discharge from hospital.

Time frame
1 week postoperatively
3

Intraoperative blood loss

Intraoperative blood loss will be recorded.

Time frame
Intraoperatively
4

Operative time

Operative time will be recorded from the start of surgery till the end of surgery.

Time frame
Intraoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov
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