Clinical trial NCT06523426: Ambulatory Geriatric Endoscopic Spine
Official title: Evaluation of Ambulatory Endoscopic Spinal Surgery in the Geriatric Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Decompression
Keywords: outpatient surgery
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient for whom an indication for ambulatory endoscopic surgery

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Success of outpatient care : Number of patient with convention hospitalization or readmission after endoscopic surgery
timeFrame: 3 months visit
Secondary outcomes:
measure: Evaluation of Treatment Efficacy
timeFrame: Inclusion visit, 3 months visit
measure: Evaluation of Treatment Safety
timeFrame: Inclusion visit, 3 months visit
measure: Evaluation of Treatment Safety
timeFrame: Inclusion visit, 3 months visit
measure: Evaluation of Treatment Safety
timeFrame: Inclusion visit, 3 months visit
measure: Evaluation of Treatment Safety
timeFrame: Inclusion visit, 3 months visit
measure: Evaluation of Treatment Safety
timeFrame: Inclusion visit, 3 months visit
measure: Evaluation of Treatment Efficacy
timeFrame: Inclusion visit, 3 months visit
measure: Evaluation of Treatment Efficacy
timeFrame: Inclusion visit, 3 months visit
measure: Evaluation of Treatment Efficacy
timeFrame: Inclusion visit, 3 months visit
measure: Evaluation of Treatment Efficacy
timeFrame: Inclusion visit, 3 months visit
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU DE Bordeaux
city: Bruges
country: France
facility: Cliniques Terrefort Bordeaux-Bruges
city: Saint-Jean-de-Védas
country: France
facility: Clinique Saint Jean - Sud de France
city: Saint-Jean-de-Védas
country: France
facility: Clinique Saint Jean - Sud de France
Study officials:
affiliation: University Hospital, Bordeaux
name: Benjamin BOUYER, PROF
role: PRINCIPAL_INVESTIGATOR
References: