Evaluation of an Enhanced Recovery Protocol After Minimally Invasive Lumbar Surgery.
NCT ID: NCT05015036
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
100 participants
OBSERVATIONAL
2022-02-28
2023-09-07
Brief Summary
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The patient will be assessed during 4 visits: At inclusion before surgery, at D0 (day of surgery), at D1 (postoperative visit) and at M1 (follow-up visit).
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Detailed Description
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Primary objective To compare the percentage of therapeutic success achieved in each group one month after surgery.
Secondary objectives: to compare between groups:
* Postoperative pain intensity at D1 and M1
* Analgesic consumption (in stages) at D1 and M1
* Pain-free walking distance at M1
* Surgery conditions (duration of operation, duration of hospitalisation)
* Frequency of adverse events related to surgery (infection rate, 1 month recovery rate, transfusion requirements)
* Emotional impact of the management
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Minimally invasive surgery of the lumbar spine with ERAS
Minimally invasive surgery of the lumbar spine with Enhanced Recovery After Surgery (ERAS)
ERAS
Minimally invasive surgery of the lumbar spine with Enhanced Recovery After Surgery (ERAS)
Minimally invasive surgery of the lumbar spine
Minimally invasive surgery of the lumbar spine
Minimally invasive surgery
Classic Minimally invasive surgery of the lumbar spine
Interventions
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ERAS
Minimally invasive surgery of the lumbar spine with Enhanced Recovery After Surgery (ERAS)
Minimally invasive surgery
Classic Minimally invasive surgery of the lumbar spine
Eligibility Criteria
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Inclusion Criteria
* Patient who has agreed to participate in the study and has read and signed the consent form for participation in the study
* Patient for whom a minimally invasive spine surgery is planned: (dicectomy, lumbar canal recalibration with or without laminectomy, lumbar arthrodesis by posterior approach limited to one stage)
Exclusion Criteria
* A bedridden or institutionalised patient
* Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
* Patient not affiliated to the French social security system
* Patient under legal protection, guardianship or curatorship
* Patient already included in another therapeutic study protocol
18 Years
ALL
No
Sponsors
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GCS Ramsay Santé pour l'Enseignement et la Recherche
OTHER
Responsible Party
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Principal Investigators
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Arthur ANDRE, MD
Role: PRINCIPAL_INVESTIGATOR
Clinique Geoffroy Saint-Hilaire
Locations
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Clinique Geoffroy Saint-Hilaire
Paris, , France
Countries
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Other Identifiers
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2020-A02669-30
Identifier Type: -
Identifier Source: org_study_id
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