Endoscopic Versus Open Lumbar Discectomy in Diabetic Patients

Not Applicable

Not yet recruiting

• Conditions: Endoscope; Open; Lumbar Discectomy; Diabetes Mellitus

• Registration Number: NCT07060846
• Lead Sponsor: Al-Azhar University

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11
• Study Start: 2025-07-15
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Degree of low back pain	48 hours postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Degree of radicular pain	48 hours postoperatively	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.
Length of hospital stay	1 week postoperatively	Length of hospital stay will be recorded from admission till discharge from hospital.
Intraoperative blood loss	Intraoperatively	Intraoperative blood loss will be recorded.
Operative time	Intraoperatively	Operative time will be recorded from the start of surgery till the end of surgery.
Wound length	Intraoperatively	Wound length will be recorded.

Trial Locations

Locations (1)

Al-Azhar University (Damietta); 🇪🇬 Damietta, Egypt