Ambulatory Geriatric Endoscopic Spine

NCT06523426 | Recruiting

• 1 other identifier: CHUBX 2023/92
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 4

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

Conditions

Lumbar Decompression

Keywords

outpatient surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Evaluation of Treatment Efficacy

  Inclusion visit, 3 months visit

• Evaluation of Treatment Safety

  Inclusion visit, 3 months visit

• Evaluation of Treatment Safety

  Inclusion visit, 3 months visit

• Evaluation of Treatment Safety

  Inclusion visit, 3 months visit

• Evaluation of Treatment Safety

  Inclusion visit, 3 months visit

Study Arms (1)

Patient treated by spinal endoscopy

elderly patients, over 75 years old, treated by spinal endoscopy

Diagnostic Test: Patient treated by spinal endoscopy

Interventions

Patient treated by spinal endoscopy DIAGNOSTIC_TEST

Questionnaire administered by surgeon; assessment of level of autonomy for activities of daily living

Patient treated by spinal endoscopy

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient for whom an indication for ambulatory endoscopic surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (4)

CHU DE Bordeaux

Bordeaux, France

RECRUITING

Cliniques Terrefort Bordeaux-Bruges

Bruges, 33520, France

NOT YET RECRUITING

Clinique Saint Jean - Sud de France

Saint-Jean-de-Védas, 24430, France

NOT YET RECRUITING

Clinique Saint Jean - Sud de France

Saint-Jean-de-Védas, 24430, France

NOT YET RECRUITING

Study Officials

• Benjamin BOUYER, PROF

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin BOUYER, PROF

CONTACT

+335 56 79 87 18; b.bouyer@chu-bordeaux.fr

Sébastien RODRIGUES-FERREIRA

CONTACT

sebastien.rodrigues-ferreira@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 26, 2024
• Study Start: September 18, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

FR (4)