Ambulatory Geriatric Endoscopic Spine (AGES)

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

Study Overview

• Status: Recruiting
• Conditions: Lumbar Decompression
• Intervention / Treatment: Diagnostic test: Patient treated by spinal endoscopy

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Benjamin BOUYER, PROF; Phone Number: +335 56 79 87 18; Email: b.bouyer@chu-bordeaux.fr
• Study Contact Backup: Name: Sébastien RODRIGUES-FERREIRA; Email: sebastien.rodrigues-ferreira@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • CHU de Bordeaux
    • Contact: Benjamin BOUYER, PROF; Phone Number: +335 56 79 87 18; Email: b.bouyer@chu-bordeaux.fr
  • Bruges, France, 33520
    • Not yet recruiting
    • Cliniques Terrefort Bordeaux-Bruges
    • Contact: Nicolas PELLET, MD; Phone Number: +335 35 54 41 41; Email: dr.pellet@cliniquesterrefort.fr
  • Saint-Jean-de-Védas, France, 24430
    • Not yet recruiting
    • Clinique Saint Jean - Sud de France
    • Contact: Alexandre DHENIN, MD; Phone Number: +334 67 41 34 53; Email: adhenin13@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient for whom an indication for ambulatory endoscopic surgery

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient treated by spinal endoscopy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Inclusion visit, 3 months visit
Evaluation of Treatment Safety	Number of serious medical complications	Inclusion visit, 3 months visit
Evaluation of Treatment Safety	Number of surgical site infections.	Inclusion visit, 3 months visit
Evaluation of Treatment Safety	Number of mechanical complications.	Inclusion visit, 3 months visit
Evaluation of Treatment Safety	Number of neurological complications.	Inclusion visit, 3 months visit
Evaluation of Treatment Safety	Number of surgical re-interventions.	Inclusion visit, 3 months visit
Evaluation of Treatment Efficacy	Evaluation of quality of life by self-questionnaire EQ-5D-5L	Inclusion visit, 3 months visit
Evaluation of Treatment Efficacy	Evaluation of geriatric autonomy by IADL.	Inclusion visit, 3 months visit
Evaluation of Treatment Efficacy	Evaluation of quality of life by self-questionnaire ODI	Inclusion visit, 3 months visit
Evaluation of Treatment Efficacy	Evaluation of quality of life by self-questionnaire SF-36	Inclusion visit, 3 months visit

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Benjamin BOUYER, PROF, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: outpatient surgery
• Other Study ID Numbers: CHUBX 2023/92

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No