Actively Recruiting
Endoscopic Versus Open Lumbar Discectomy in Diabetic Patients: A Randomized Controlled Trial
Led by Al-Azhar University · Updated on 2025-07-22
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two surgical techniques—endoscopic and open lumbar discectomy—in patients with diabetes mellitus who have a prolapsed lumbar disc causing low back pain and radiculopathy. Diabetes is a common disease that can affect many organs and increase risks during medical and surgical treatments. The study aims to determine differences in outcomes between the less invasive endoscopic method and the traditional open surgery approach. Participants will be randomly assigned to one of two groups. One group will receive endoscopic lumbar discectomy, a minimally invasive surgery using an endoscope to relieve nerve pressure. The other group will undergo the conventional open lumbar discectomy, which is considered the standard technique. Both methods target herniated discs at a single spinal level (L4-5 or L5-S1). During the trial, researchers will assess pain levels 48 hours after surgery, including low back and radicular pain. They will also measure operative factors such as blood loss, procedure duration, wound length, and hospital stay length up to one week postoperatively. Participants will be monitored closely to collect these outcomes, ensuring thorough evaluation of each surgical approach over the course of recovery.
CONDITIONS
Brief Title
Endoscopic Versus Open Lumbar Discectomy in Diabetic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 75 years
- Both sexes
- Patients with a prolapsed lumbar disc at L4-5 or L5-S1 causing low back pain and unilateral radiculopathy
- Failure of conservative treatment for 12 weeks
You will not qualify if you...
- Extraforaminal disc herniation
- Recurrent or multiple level disc prolapses
- Spondylolisthesis
- Prior lumbar surgery at the same spinal level
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week or until discharge
Participants undergo either endoscopic or open lumbar discectomy surgery to relieve symptoms caused by a prolapsed lumbar disc.
Hospital stay with monitoring during and immediately after surgery
Duration - Up to 1 week postoperatively
Participants are followed up to assess pain levels, wound healing, and recovery progress after surgery.
1 follow-up visit approximately 1 week after surgery
Trial Site Locations
Total: 1 location
1
Al-Azhar University (Damietta)
Damietta, Egypt, 0000-0001-6746-3024
Actively Recruiting
Research Team
A
Awad M Hegab, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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