Endoscopic Versus Open Lumbar Discectomy in Diabetic Patients

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

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Open; Lumbar Discectomy; Endoscope
• Intervention / Treatment: Procedure: Endoscopic lumbar discectomy; Procedure: Open lumbar discectomy

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Awad M Hegab, MD; Phone Number: 00201061833482; Email: Dr.awadhegab@gmail.com

Study Locations

• Egypt
  • Damietta, Egypt, 0000-0001-6746-3024
    • Recruiting
    • Al-Azhar University (Damietta)
    • Contact: Awad M Hegab, MD; Phone Number: 00201061833482; Email: Dr.awadhegab@gmail.com
    • Principal Investigator: Ahmed Taha, MD
    • Principal Investigator: Mahmoud Elrabaie, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Patients will undergo endoscopic lumbar discectomy.	Procedure: Endoscopic lumbar discectomy; Patients will undergo endoscopic lumbar discectomy.
Active Comparator: Group II; Patients will undergo an open lumbar discectomy.	Procedure: Open lumbar discectomy; Patients will undergo an open lumbar discectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours postoperatively
Length of hospital stay	Length of hospital stay will be recorded from admission till discharge from hospital.	1 week postoperatively
Intraoperative blood loss	Intraoperative blood loss will be recorded.	Intraoperatively
Operative time	Operative time will be recorded from the start of surgery till the end of surgery.	Intraoperatively
Wound length	Wound length will be recorded.	Intraoperatively

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 2, 2025
• First Submitted That Met QC Criteria: July 2, 2025
• First Posted (Actual): July 11, 2025

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 19, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus
• Other Study ID Numbers: DFM-IRB 00012367-25-06-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Access Criteria: After the end of study for one year.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No