Lumbar DecompressionAGESNCT06523426
Ambulatory Geriatric Endoscopic Spine
An observational study of Lumbar Decompression, run by University Hospital, Bordeaux at 4 sites in France.
Trial summary
The research focuses on evaluating the clinical outcomes of endoscopic lumbar decompression surgery performed in an outpatient setting for patients over 75 years old. This prospective, multicentric, non-interventional study aims to assess the feasibility and effectiveness of endoscopic techniques, specifically… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Lumbar Decompression
- What is being tested?
- Patient treated by spinal endoscopy
- How many people
- 50 participants
- Where
- 4 sitesFrance
- Study dates
- 18 Sep 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patient for whom an indication for ambulatory endoscopic surgery
Who may be able to join
- Patient aged over 75 years.
- Patient consulting for a medical condition involving a spinal pathology at the center, for which endoscopic lumbar decompression on one level is indicated.
Who cannot join
- Patients under guardianship or trusteeship.
- Individuals deprived of liberty by judicial or administrative decision.
- Individuals undergoing psychiatric treatment under constraint requiring consent from a legal representative.
- Individuals admitted to a health or social institution for purposes other than research.
- Individuals unable to give consent.
- Individuals under legal protection.
- Patients not affiliated with a social security system.
- Patients suffering from infectious, traumatic, or tumoral spinal pathology.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sébastien RODRIGUES-FERREIRA contact
France4 sites, 4 recruiting
- Recruiting
CHU DE Bordeaux
Bordeaux
Benjamin BOUYER, PROF, +335 56 79 87 18, b.bouyer@chu-bordeaux.fr
- Not yet recruiting
Cliniques Terrefort Bordeaux-Bruges
Bruges, 33520
Nicolas PELLET, MD, +335 35 54 41 41, dr.pellet@cliniquesterrefort.fr
- Not yet recruiting
Clinique Saint Jean - Sud de France
Saint-Jean-de-Védas, 24430
Guillaume LONJON, MD, +334 67 41 34 53, guilonjon@gmail.com
- Not yet recruiting
Clinique Saint Jean - Sud de France
Saint-Jean-de-Védas, 24430
Alexandre DHENIN, MD, +334 67 41 34 53, adhenin13@gmail.com
About this study
Official title: Evaluation of Ambulatory Endoscopic Spinal Surgery in the Geriatric Population
The research focuses on evaluating the clinical outcomes of endoscopic lumbar decompression surgery performed in an outpatient setting for patients over 75 years old. This prospective, multicentric, non-interventional study aims to assess the feasibility and effectiveness of endoscopic techniques, specifically biportal and uniportal approaches, in reducing operative morbidity and hospital stay duration within this demographic. The primary objective is to determine the success rate of outpatient treatment using these endoscopic procedures in elderly patients
Read the detailed description
This study investigates the clinical outcomes of endoscopic lumbar decompression surgery performed in an outpatient setting for patients over 75 years old. Given the increasing prevalence of spinal pathologies in aging populations, traditional surgical approaches pose significant morbidity and extended hospital stays, especially for the elderly. Recent advancements in less invasive endoscopic techniques offer promising alternatives that may reduce these risks. This prospective, multicentric, non-interventional study aims to evaluate the feasibility and effectiveness of endoscopic lumbar decompression, specifically biportal and uniportal approaches, in reducing operative morbidity and hospital stay duration within this demographic.
Scientific Justification Spinal pathologies, particularly degenerative conditions of the lumbar spine, are common and lead to significant healthcare costs. With the aging population in developed countries, the incidence of these pathologies is increasing, with 100% of individuals over 60 years old showing structural degenerative changes and 60% experiencing related symptoms. Current surgical treatments, such as conventional lumbar decompression, often result in prolonged hospital stays and high morbidity, particularly among the elderly who typically present with multiple comorbidities, increased bone fragility, and functional limitations. Endoscopic surgery, a less invasive alternative, has demonstrated excellent outcomes in recent studies, including lower complication rates and shorter recovery times. However, its effectiveness in the outpatient setting for the geriatric population remains unstudied.
Treatment/Strategy/Procedure The study involves endoscopic lumbar decompression surgery, utilizing either biportal or uniportal techniques, performed on patients over 75 years old in an outpatient setting. This approach aims to minimize surgical trauma and preserve the physiological function and stability of the lumbar spine.
Follow-Up Patients will be followed for three months post-surgery to monitor clinical improvements and identify any peri- or post-operative complications. Data collected will include clinical examinations, quality of life assessments, medical history, ongoing treatments, and responses to self-administered questionnaires. The follow-up visit at three months will gather comprehensive information on patient progress, including clinical examinations, imaging data, therapeutic interventions, and medication use.
- Conditions
- Lumbar Decompression
- Being tested
- Patient treated by spinal endoscopy
- Keywords
- outpatient surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient treated by spinal endoscopyDiagnostic test
Questionnaire administered by surgeon; assessment of level of autonomy for activities of daily living
| Study group | Role | What they receive |
|---|---|---|
| Patient treated by spinal endoscopy | elderly patients, over 75 years old, treated by spinal endoscopy Receives: Diagnostic Test: Patient treated by spinal endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of outpatient care : Number of patient with convention hospitalization or readmission after endoscopic surgery
The success of ambulatory management is the number of patients for whom an indication for endoscopic surgery is given and performed without the need for conventional hospitalization secondary to surgery, or readmission within 30 days of surgery
Measured: 3 months visit
Secondary outcomes (10)
Evaluation of Treatment Efficacy
Evolution of perceived health scores specific to the treated pathology. ODI (Oswestry Disability Index) is a self-questionnaire with 10 items. Each question is rated from 0 to 5 and total score that varies from 0 to 50
Measured: Inclusion visit, 3 months visit
Evaluation of Treatment Safety
Number of serious medical complications
Measured: Inclusion visit, 3 months visit
Evaluation of Treatment Safety
Number of surgical site infections.
Measured: Inclusion visit, 3 months visit
Evaluation of Treatment Safety
Number of mechanical complications.
Measured: Inclusion visit, 3 months visit
Evaluation of Treatment Safety
Number of neurological complications.
Measured: Inclusion visit, 3 months visit
Evaluation of Treatment Safety
Number of surgical re-interventions.
Measured: Inclusion visit, 3 months visit
Evaluation of Treatment Efficacy
Evaluation of quality of life by self-questionnaire EQ-5D-5L
Measured: Inclusion visit, 3 months visit
Evaluation of Treatment Efficacy
Evaluation of geriatric autonomy by IADL.
Measured: Inclusion visit, 3 months visit
Evaluation of Treatment Efficacy
Evaluation of quality of life by self-questionnaire ODI
Measured: Inclusion visit, 3 months visit
Evaluation of Treatment Efficacy
Evaluation of quality of life by self-questionnaire SF-36
Measured: Inclusion visit, 3 months visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start18 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar DecompressionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin BOUYER, PROF, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523426
- Sponsor's protocol ID
- CHUBX 2023/92
- Acronym
- AGES
- Status last verified
- Nov 2024
- First submitted
- 9 Jul 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ambulatory Endoscopic Spinal Surgery in the Geriatric Population
- ClinicalTrials.gov ID
- NCT06523426
- Acronym / sponsor ID
- AGES / CHUBX 2023/92
- Conditions
- Lumbar Decompression
- Keywords
- outpatient surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jul 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.
The research focuses on evaluating the clinical outcomes of endoscopic lumbar decompression surgery performed in an outpatient setting for patients over 75 years old. This prospective, multicentric, non-interventional study aims to assess the feasibility and effectiveness of endoscopic techniques, specifically biportal and uniportal approaches, in reducing operative morbidity and hospital stay duration within this demographic. The primary objective is to determine the success rate of outpatient treatment using these endoscopic procedures in elderly patients
Detailed description
This study investigates the clinical outcomes of endoscopic lumbar decompression surgery performed in an outpatient setting for patients over 75 years old. Given the increasing prevalence of spinal pathologies in aging populations, traditional surgical approaches pose significant morbidity and extended hospital stays, especially for the elderly. Recent advancements in less invasive endoscopic techniques offer promising alternatives that may reduce these risks. This prospective, multicentric, non-interventional study aims to evaluate the feasibility and effectiveness of endoscopic lumbar decompression, specifically biportal and uniportal approaches, in reducing operative morbidity and hospital stay duration within this demographic.
Scientific Justification Spinal pathologies, particularly degenerative conditions of the lumbar spine, are common and lead to significant healthcare costs. With the aging population in developed countries, the incidence of these pathologies is increasing, with 100% of individuals over 60 years old showing structural degenerative changes and 60% experiencing related symptoms. Current surgical treatments, such as conventional lumbar decompression, often result in prolonged hospital stays and high morbidity, particularly among the elderly who typically present with multiple comorbidities, increased bone fragility, and functional limitations. Endoscopic surgery, a less invasive alternative, has demonstrated excellent outcomes in recent studies, including lower complication rates and shorter recovery times. However, its effectiveness in the outpatient setting for the geriatric population remains unstudied.
Treatment/Strategy/Procedure The study involves endoscopic lumbar decompression surgery, utilizing either biportal or uniportal techniques, performed on patients over 75 years old in an outpatient setting. This approach aims to minimize surgical trauma and preserve the physiological function and stability of the lumbar spine.
Follow-Up Patients will be followed for three months post-surgery to monitor clinical improvements and identify any peri- or post-operative complications. Data collected will include clinical examinations, quality of life assessments, medical history, ongoing treatments, and responses to self-administered questionnaires. The follow-up visit at three months will gather comprehensive information on patient progress, including clinical examinations, imaging data, therapeutic interventions, and medication use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient treated by spinal endoscopy | – | Diagnostic Test: Patient treated by spinal endoscopyelderly patients, over 75 years old, treated by spinal endoscopy |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patient for whom an indication for ambulatory endoscopic surgery
Key inclusion criteria (2 listed)
- Patient aged over 75 years.
- Patient consulting for a medical condition involving a spinal pathology at the center, for which endoscopic lumbar decompression on one level is indicated.
Key exclusion criteria (8 listed)
- Patients under guardianship or trusteeship.
- Individuals deprived of liberty by judicial or administrative decision.
- Individuals undergoing psychiatric treatment under constraint requiring consent from a legal representative.
- Individuals admitted to a health or social institution for purposes other than research.
- Individuals unable to give consent.
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 |
|---|---|---|
| Patient treated by spinal endoscopyQuestionnaire administered by surgeon; assessment of level of autonomy for activities of daily living | Diagnostic test | Patient treated by spinal endoscopy |
Primary outcome
Success of outpatient care : Number of patient with convention hospitalization or readmission after endoscopic surgery
Time frame: 3 months visit
The success of ambulatory management is the number of patients for whom an indication for endoscopic surgery is given and performed without the need for conventional hospitalization secondary to surgery, or readmission within 30 days of surgery
10 secondary outcomes
Evaluation of Treatment Efficacy
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Safety
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Safety
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Safety
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Safety
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Safety
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Efficacy
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Efficacy
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Efficacy
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Efficacy
Time frame: Inclusion visit, 3 months visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
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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.
Sébastien RODRIGUES-FERREIRA contact
Benjamin BOUYER, PROF principal investigator
University Hospital, Bordeaux
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Decompression, run by University Hospital, Bordeaux at 4 sites 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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin BOUYER, PROF (+335 56 79 87 18, b.bouyer@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of outpatient care : Number of patient with convention hospitalization or readmission after endoscopic surgery (time frame: 3 months visit). 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 18 Nov 2024.