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Endoscopic Versus Open Lumbar Discectomy in Diabetic Patients

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07060846
Enrollment
50
Registered
2025-07-11
Start date
2025-07-19
Completion date
2025-12-01
Last updated
2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Endoscope, Lumbar Discectomy, Open

Brief summary

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

Patients will undergo endoscopic lumbar discectomy.

PROCEDUREOpen lumbar discectomy

Patients will undergo an open lumbar discectomy.

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Degree of low back pain48 hours postoperativelyThe 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.

Secondary

MeasureTime frameDescription
Degree of radicular pain48 hours postoperativelyThe 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.
Length of hospital stay1 week postoperativelyLength of hospital stay will be recorded from admission till discharge from hospital.
Intraoperative blood lossIntraoperativelyIntraoperative blood loss will be recorded.
Operative timeIntraoperativelyOperative time will be recorded from the start of surgery till the end of surgery.
Wound lengthIntraoperativelyWound length will be recorded.

Countries

Egypt

Contacts

Primary ContactAwad M Hegab, MD
Dr.awadhegab@gmail.com00201061833482

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026