Ambulatory Geriatric Endoscopic Spine
ConditionLumbar Decompression
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age75+
SponsorUniversity Hospital, Bordeaux
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patient for whom an indication for ambulatory endoscopic surgery
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Patient treated by spinal endoscopy
Diagnostic testQuestionnaire administered by surgeon; assessment of level of autonomy for activities of daily living
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Patient treated by spinal endoscopy1 intervention
Trial outcomes
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
Time frame
3 months visitSecondary outcomes
1
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 visit2
Evaluation of Treatment Safety
Number of serious medical complications
Time frame
Inclusion visit, 3 months visit3
Evaluation of Treatment Safety
Number of surgical site infections.
Time frame
Inclusion visit, 3 months visit4
Evaluation of Treatment Safety
Number of mechanical complications.
Time frame
Inclusion visit, 3 months visitSponsors and contacts
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Source ClinicalTrials.gov