NCT07151651

Brief Summary

This study aims to provide a detailed comparison between different methods of lumbar discectomy by the use of different types of spine endoscopy to evaluate the benefits and drawbacks of each type

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Sep 2025Sep 2027

First Submitted

Initial submission to the registry

August 19, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 19, 2025

Last Update Submit

August 25, 2025

Conditions

Keywords

Lumar discectomyEndoscopyUniportalBiportal

Outcome Measures

Primary Outcomes (1)

  • Primary outcome measures After endoscopic lumbar discectomy Pain relief

    1-Pain Relief: Visual Analog Scale (VAS for leg and back pain)

    12 weeks up to 2 years

Study Arms (1)

Patients with lumbar disc prolapse

ACTIVE COMPARATOR

1. Patients aged 18-70 years. 2. single-level lumbar disc herniation (L3-L4, L4-L5, or L5-S1) confirmed by MRI. 3. Persistent symptoms not responding to conservative management (≥6 weeks).

Procedure: Endoscopic lumbar discectomy

Interventions

Uniportal and boportal endoscopic lumbar discectomy (transforaminal or interlaminar)

Patients with lumbar disc prolapse

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients should fulfill the following criteria
  • Patients aged 18-70 years.
  • single-level lumbar disc herniation (L3-L4, L4-L5, or L5-S1) confirmed by MRI.
  • Persistent symptoms not responding to conservative management (≥6 weeks).

You may not qualify if:

  • All patients should not have any of the following criteria
  • Multilevel disc herniation.
  • Previous lumbar spine surgery, trauma or injection.
  • Severe spinal stenosis.
  • Severe osteoporosis, infection, or malignancy or autoimmune disease affecting the spine.
  • Uncontrolled medical comorbidities contraindicating surgery.
  • Instability: spondylolisthesis\>grade 1
  • Marked obesity.(BMI \>35-40 kg/m2 )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Sohag Governorate, 002, Egypt

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

mohamed Ibrahim Amin, Assesstant lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A prospective study will be conducted at Sohag and Cairo University Hospitals on 60 patients diagnosed with lumbar disc herniation, undergoing endoscopic lumbar discectomy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer at neurosurgery department sohag University

Study Record Dates

First Submitted

August 19, 2025

First Posted

September 3, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

September 3, 2025

Record last verified: 2025-08

Locations