Endoscopic Versus Open Lumbar Discectomy in Diabetic Patients

NCT07060846 | Recruiting

• 1 other identifier: DFM-IRB 00012367-25-06-009
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endoscope; Open; Lumbar Discectomy; Diabetes Mellitus

Outcome Measures

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.

  48 hours postoperatively

Secondary Outcomes (5)

• Degree of radicular pain

  48 hours postoperatively

• Length of hospital stay

  1 week postoperatively

• Intraoperative blood loss

  Intraoperatively

• Operative time

  Intraoperatively

• Wound length

  Intraoperatively

Study Arms (2)

Group I

EXPERIMENTAL

Patients will undergo endoscopic lumbar discectomy.

Procedure: Endoscopic lumbar discectomy

Group II

ACTIVE COMPARATOR

Patients will undergo an open lumbar discectomy.

Procedure: Open lumbar discectomy

Interventions

Endoscopic lumbar discectomy PROCEDURE

Patients will undergo endoscopic lumbar discectomy.

Group I

Open lumbar discectomy PROCEDURE

Patients will undergo an open lumbar discectomy.

Group II

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Extraforaminal disc herniation.
• Recurrent and/or multiple level discs prolapses.
• Spondylolisthesis.
• Prior lumbar surgery at the same spinal level.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University (Damietta)

Damietta, 0000-0001-6746-3024, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Awad M Hegab, MD

CONTACT

00201061833482; Dr.awadhegab@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Neurosurgery, Faculty of Medicine, Al-Azhar University, Damietta, Egypt.

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: July 19, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available upon a reasonable request from the corresponding author.
• Access Criteria: After the end of study for one year.

Locations

EG (1)