Endoscopic Versus Open Lumbar Discectomy in Diabetic Patients

NCT ID: NCT07060846

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-19

Study Completion Date

2025-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Endoscope Open Lumbar Discectomy Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I

Patients will undergo endoscopic lumbar discectomy.

Group Type EXPERIMENTAL

Endoscopic lumbar discectomy

Intervention Type PROCEDURE

Patients will undergo endoscopic lumbar discectomy.

Group II

Patients will undergo an open lumbar discectomy.

Group Type ACTIVE_COMPARATOR

Open lumbar discectomy

Intervention Type PROCEDURE

Patients will undergo an open lumbar discectomy.

Interventions

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Endoscopic lumbar discectomy

Patients will undergo endoscopic lumbar discectomy.

Intervention Type PROCEDURE

Open lumbar discectomy

Patients will undergo an open lumbar discectomy.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Awad Mohamed Hegab

Lecturer of Neurosurgery, Faculty of Medicine, Al-Azhar University, Damietta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Azhar University (Damietta)

Damietta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Awad M Hegab, MD

Role: CONTACT

00201061833482

Facility Contacts

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Awad M Hegab, MD

Role: primary

00201061833482

Other Identifiers

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DFM-IRB 00012367-25-06-009

Identifier Type: -

Identifier Source: org_study_id

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