ERAMIS: Evaluation of an Enhanced Recovery Protocol After Minimally Invasive Lumbar Surgery.
Study Details
Study Description
Brief Summary
Prospective longitudinal multicentre observational study carried out on a population of patients undergoing minimally invasive spine surgery and divided into two parallel cohorts according to the presence or absence of a Enhanced Recovery After Surgery (ERAS) programme.
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
On a population of patients undergoing minimally invasive lumbar spine surgery divided into two cohorts of equal size according to the presence or absence of a Enhanced Recovery After
Surgery (ERAS) programme:
Primary objective To compare the percentage of therapeutic success achieved in each group one month after surgery.
Secondary objectives: to compare between groups:
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Postoperative pain intensity at D1 and M1
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Analgesic consumption (in stages) at D1 and M1
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Pain-free walking distance at M1
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Surgery conditions (duration of operation, duration of hospitalisation)
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Frequency of adverse events related to surgery (infection rate, 1 month recovery rate, transfusion requirements)
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Emotional impact of the management
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Minimally invasive surgery of the lumbar spine with ERAS Minimally invasive surgery of the lumbar spine with Enhanced Recovery After Surgery (ERAS) |
Procedure: 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 |
Procedure: Minimally invasive surgery
Classic Minimally invasive surgery of the lumbar spine
|
Outcome Measures
Primary Outcome Measures
- Oswestry Disability Index improvement [Month 1]
The Oswestry Disability Index (Appendix 1) (also known as the Oswestry Low Back Pain Disability) is the gold standard tool for assessing functional disability related to low back pain and functional recovery after surgery. It consists of ten questions rated from 0 to 5 (from most to least favourable). The result is expressed as a percentage according to the following formula [score obtained / (maximum score)] X 100. The maximum score is 50 if all the questions have been filled in, 45 if one question has not been filled in etc..... The disability rate, corresponding to the percentage, obtained is considered minimal between 0 and 20%, moderate between 21 and 40% and severe above 41%. Therapeutic success defined as an improvement ≥30% in the Oswestry Disability Index between initial and final visit is the primary endpoint
Secondary Outcome Measures
- Post-operative pain [Day 1]
The intensity of the pain will be assessed using a simple numerical scale (ENS) graduated from 0 (no pain) to 10 (worst pain imaginable).
- Post-operative pain [Month 1]
The intensity of the pain will be assessed using a simple numerical scale (ENS) graduated from 0 (no pain) to 10 (worst pain imaginable).
- Consumption of level I, II and II analgesics [Day 1]
Consumption of level I, II and II analgesics. Count of treatments
- Consumption of level I, II and II analgesics [Month 1]
Consumption of level I, II and II analgesics
- Pain-free walking perimeter [Month 1]
Measurement in meters of the distance the patient travels until he/she is forced to stop due to pain
- Evolution of Hospital Anxiety and Depression (HAD) scale score and sub-scores [Month 1]
The emotional impact of the disease will be more precisely evaluated by the Hospital Anxiety and Depression (HAD) questionnaire, a screening tool for the most common manifestations of anxiety and depressive disorders to be completed by the patient. The scale comprises 14 questions, with 7 items assessing anxiety and 7 items assessing depression. A minimum score of 10 on one of the sub-scores was retained as a criterion for detecting depressive or anxious manifestations. The HAD questionnaire will be completed by the patient at the inclusion visit (V1) and at the end of the study (V4).
- Duration of intervention [Day 1]
Duration of the surgery in hours
- Length of hospital stay [Month 1]
Length of hospital stay in days
- Adverse events related to surgery [Month 1]
All adverse events related to surgery will be collected and compared in the 2 groups
- Visual Analogue Scale overall patient satisfaction [Month 1]
The patient's satisfaction with his or her treatment and results will be assessed at the end of the study on a visual analogue scale graduated from 0 (very dissatisfied) to 10 (very satisfied).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult male or female (18 years or older)
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Patient who has agreed to participate in the study and has read and signed the consent form for participation in the study
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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:
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Patient with a contraindication to spinal anaesthesia
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A bedridden or institutionalised patient
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Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
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Patient not affiliated to the French social security system
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Patient under legal protection, guardianship or curatorship
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Patient already included in another therapeutic study protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinique Geoffroy Saint-Hilaire | Paris | France | 75005 |
Sponsors and Collaborators
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Investigators
- Principal Investigator: Arthur ANDRE, MD, Clinique Geoffroy Saint-Hilaire
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-A02669-30