Management of Lumbar Discectomy by Endoscopy and Conventional Microscopic Discectomy (ENDOLOMB)

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.

Study Overview

• Status: Recruiting
• Conditions: Radiculopathy
• Intervention / Treatment: Procedure: Discectomy

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.

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 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.

• Study Type: Observational
• Enrollment (Estimated): 440

Contacts and Locations

• Study Contact: Name: HENRI D'ASTORG, MD; Phone Number: + 33 6 61 38 77 12; Email: h.dastorg@gmail.com

Study Locations

• France
  • Toutes
    • Lyon, Toutes, France, 69008
      • Recruiting
      • Hopital Prive Jean Mermoz
      • Contact: HENRI D'ASTORG, MD; Phone Number: +33661387712; Email: h.dastorg@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who need discetomy for lumbar disc herniation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgery under full endoscopy; A full endoscopic surgery will be performed on patienst with herniated disc	Procedure: Discectomy; Discectomy is total or more often partial intervertebral disc surgical removal
Conventional microscopic surgery; A conventional microscopic surgery will be performed on patienst with herniated disc	Procedure: Discectomy; Discectomy is total or more often partial intervertebral disc surgical removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: RGDS-2022-06-025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No