Management of Lumbar Discectomy by Endoscopy and Conventional Microscopic Discectomy

Radiculopathy Clinical Trial

— ENDOLOMB  

Official title:

Management of Lumbar Discectomy by Endoscopy and Conventional Microscopic Discectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06193265
• Other study ID #: RGDS-2022-06-025
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: HENRI D'ASTORG, MD
• Phone: + 33 6 61 38 77 12
• Email: h.dastorg[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Radiculopathy

Intervention

Procedure:
• Discectomy
Discectomy is total or more often partial intervertebral disc surgical removal

Locations

Country	Name	City	State
France	Hôpital Privé Jean Mermoz	Lyon	Toutes

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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