RadiculopathyENDOLOMBNCT06193265
Management of Lumbar Discectomy by Endoscopy and Conventional Microscopic Discectomy
An observational study of Radiculopathy, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiculopathy
- What is being tested?
- Discectomy
- Type of treatment
- Surgery or procedure
- How many people
- 539 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who need discetomy for lumbar disc herniation
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Radiculopathy
- Being tested
- Discectomy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiscectomyProcedure or surgery
Discectomy is total or more often partial intervertebral disc surgical removal
| Study group | Role | What they receive |
|---|---|---|
| Surgery under full endoscopy | A full endoscopic surgery will be performed on patienst with herniated disc Receives: Procedure: Discectomy | |
| Conventional microscopic surgery | A conventional microscopic surgery will be performed on patienst with herniated disc Receives: Procedure: Discectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization rate within 3 months after discectomy
Number of patients hospitalized within 3 months after surgery will be used to define re hospitalization percentage
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Nov 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiculopathyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193265
- Sponsor's protocol ID
- RGDS-2022-06-025
- Acronym
- ENDOLOMB
- Status last verified
- Feb 2024
- First submitted
- 21 Dec 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Lumbar Discectomy by Endoscopy and Conventional Microscopic Discectomy
- ClinicalTrials.gov ID
- NCT06193265
- Acronym / sponsor ID
- ENDOLOMB / RGDS-2022-06-025
- Conditions
- Radiculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery under full endoscopy | – | Procedure: DiscectomyA full endoscopic surgery will be performed on patienst with herniated disc |
| Conventional microscopic surgery | – | Procedure: DiscectomyA conventional microscopic surgery will be performed on patienst with herniated disc |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who need discetomy for lumbar disc herniation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiscectomyDiscectomy is total or more often partial intervertebral disc surgical removal | Procedure or surgery | Conventional microscopic surgery, Surgery under full endoscopy |
Primary outcome
Hospitalization rate within 3 months after discectomy
Time frame: 3 months
Number of patients hospitalized within 3 months after surgery will be used to define re hospitalization percentage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiculopathy, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization rate within 3 months after discectomy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.