A Comparison Between Biportal and Uniportal Endoscopic Lu... | NCT07151651

Studies
A Comparison Between Biportal and Uniportal Endoscopic Lumbar Discectomy

NCT07151651

Sponsor

Sohag University

Status

Not yet recruiting

Last Update Posted

Sep 3, 2025Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Lumbar Disc Herniation

Interventions

Endoscopic lumbar discectomy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2025Estimated

Primary Completion Date

Sep 1, 2026Estimated

Completion Date

Sep 1, 2027Estimated

First Submitted Date

Aug 19, 2025

First Submission Date that Met QC Criteria

Aug 25, 2025

First Posted Date

Sep 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2025

Last Update Posted Date

Sep 3, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Ibraheem Amin, Assistant lecturer at neurosurgery department sohag University, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

The aim of this study is to compare between uniportal and biportal endoscopic techniques in patients with lumbar disc herniation in terms of efficacy, safety, and learning curve of endoscopic spine surgery .The research will focus on clinical outcomes, functional recovery, complication rates, patient satisfaction and surgical proficiency in different endoscopic spine surgery techniques, including uniportal and biportal approaches assessing their relative advantages and limitations.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with lumbar disc prolapse	Active Comparator	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).	Procedure: Endoscopic lumbar discectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic lumbar discectomy	Procedure	Uniportal and boportal endoscopic lumbar discectomy (transforaminal or interlaminar)	Patients with lumbar disc prolapse

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients should fulfill the following criteria
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).

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mohamed Ibrahim Amin, Assesstant lecturer	Contact	002 010 215 64439	010 215 64439	Mohamed-ataya@med.sohag.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag University		Sohag	Sohag Governorate	002	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Data is not collected yet

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007405	Intervertebral Disc Displacement

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006547	Hernia

Browse Leaves

Not provided

Browse Branches

Not provided