Management of Lumbar Discectomy by Endoscopy and Conventi... | NCT06193265

Studies
Management of Lumbar Discectomy by Endoscopy and Conventional Microscopic Discectomy

NCT06193265

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Unknown status

Last Update Posted

Mar 1, 2024Actual

Enrollment

440Estimated

Phase

Not provided

Conditions

Radiculopathy

Interventions

Discectomy

Countries

France

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

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Actual

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Dec 21, 2023

First Submission Date that Met QC Criteria

Dec 21, 2023

First Posted Date

Jan 5, 2024Actual

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

Feb 28, 2024

Last Update Posted Date

Mar 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Currently, microscopic discectomy is performed as a minimally invasive surgery, thus reducing impact of so-called conventional "open" discectomies.

Although more technically demanding, discectomy with full endoscopy made possible a significant reduction of surgery invasive impact, thus making possible to broaden the field of endoscopic surgery indications.

This study is based on hypothesis that complete endoscopic discectomy offers several advantages over traditional microscopic discectomy, including a smaller skin incision and therefore fewer scars and less muscle damage, lower infection rate, less blood loss, less painful post-operative recovery and shorter hospital stay length.

Detailed Description

Discectomy is the most common surgical technique to solve lumbar radiculopathy caused by disc herniation and nerve roots compression .

Currently, microscopic discectomy is performed as a minimally invasive surgery, thus reducing the impact of so-called conventional "open" discectomies.

Minimally invasive spinal surgery was developed using a retractor tube, a microscope, and an endoscope to perform efficient nerves decompression while preserving spinal cord stabilizing structures.

This study is based on hypothesis that full endoscopic discectomy offers several advantages over traditional microscopic discectomy, including a smaller skin incision and therefore fewer scars and less muscle damage, lower infection rate, less blood loss, less painful post-operative recovery and shorter hospital stay length.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

440Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgery under full endoscopy		A full endoscopic surgery will be performed on patienst with herniated disc	Procedure: Discectomy
Conventional microscopic surgery		A conventional microscopic surgery will be performed on patienst with herniated disc	Procedure: Discectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Discectomy	Procedure	Discectomy is total or more often partial intervertebral disc surgical removal	Conventional microscopic surgery Surgery under full endoscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospitalization rate within 3 months after discectomy	Number of patients hospitalized within 3 months after surgery will be used to define re hospitalization percentage	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient, male or female, aged ≥ 18 years
Patient operated under endoscopy for lumbar disc herniation between February 2020 and May 2022
Patient operated by conventional microscopic surgery for lumbar disc herniation before February 2020
Patient having been informed of the research and not opposing its data use as part of this research

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who need discetomy for lumbar disc herniation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
HENRI D'ASTORG, MD	Contact	+ 33 6 61 38 77 12		h.dastorg@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Privé Jean Mermoz	Recruiting	Lyon	Toutes	69008	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011843	Radiculopathy

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017586	Diskectomy

Ancestor Terms

ID	Term
D019637	Orthopedic Procedures
D013812	Therapeutics
D019299	Decompression, Surgical
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided