Management of Lumbar Discectomy by Endoscopy and Conventional Microscopic Discectomy

NCT06193265 | Recruiting

• 1 other identifier: RGDS-2022-06-025
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiculopathy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Discectomy PROCEDURE

Discectomy is total or more often partial intervertebral disc surgical removal

Conventional microscopic surgery; Surgery under full endoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who need discetomy for lumbar disc herniation

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, Toutes, 69008, France

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Interventions

Diskectomy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative

Central Study Contacts

HENRI D'ASTORG, MD

CONTACT

+ 33 6 61 38 77 12; h.dastorg@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: November 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)