An observational study in Lumbar Decompression, sponsored by University Hospital, Bordeaux. Recruiting at 4 sites in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by University Hospital, Bordeaux · Observational
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
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.
University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient for whom an indication for ambulatory endoscopic surgery
Exclusion Criteria:
elderly patients, over 75 years old, treated by spinal endoscopy
Diagnostic Test: Patient treated by spinal endoscopy
Questionnaire administered by surgeon; assessment of level of autonomy for activities of daily living
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
Time frame: 3 months visit
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
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Safety
Number of serious medical complications
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Safety
Number of surgical site infections.
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Safety
Number of mechanical complications.
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Safety
Number of neurological complications.
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Safety
Number of surgical re-interventions.
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Efficacy
Evaluation of quality of life by self-questionnaire EQ-5D-5L
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Efficacy
Evaluation of geriatric autonomy by IADL.
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Efficacy
Evaluation of quality of life by self-questionnaire ODI
Time frame: Inclusion visit, 3 months visit
Evaluation of Treatment Efficacy
Evaluation of quality of life by self-questionnaire SF-36
Time frame: Inclusion visit, 3 months visit
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University Hospital, Bordeaux