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Recruiting

NCT Number: NCT07060846

Endoscopic Versus Open Lumbar Discectomy in Diabetic Patients

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

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University (Damietta)

Damietta, 0000-0001-6746-3024, Egypt

Location status: Recruiting

Location contact

Ahmed Taha, MD

PRINCIPAL_INVESTIGATOR

Awad M Hegab, MD

CONTACT

[email protected]

00201061833482

Mahmoud Elrabaie, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic lumbar discectomy

Procedure

Patients will undergo endoscopic lumbar discectomy.

Open lumbar discectomy

Procedure

Patients will undergo an open lumbar discectomy.

Primary outcomes

  1. Degree of low back pain

    Time frame: 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 outcomes

  1. Degree of radicular pain

    Time frame: 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.

  2. Length of hospital stay

    Time frame: 1 week postoperatively

    Length of hospital stay will be recorded from admission till discharge from hospital.

  3. Intraoperative blood loss

    Time frame: Intraoperatively

    Intraoperative blood loss will be recorded.

  4. Operative time

    Time frame: Intraoperatively

    Operative time will be recorded from the start of surgery till the end of surgery.

  5. Wound length

    Time frame: Intraoperatively

    Wound length will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Awad M Hegab, MD

CONTACT

[email protected]

00201061833482

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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