Evaluation of an Enhanced Recovery Protocol After Minimally Invasive Lumbar Surgery. (ERAMIS)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Spine Surgery
• Intervention / Treatment: Procedure: ERAS; Procedure: Minimally invasive surgery

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:

• 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

• Study Type: Observational
• Enrollment (Anticipated): 302

Contacts and Locations

• Study Contact: Name: Arthur ANDRE, MD; Phone Number: 33 06 25 40 60 69; Email: arthur.andre@neurochirurgie.fr

Study Locations

• France
  • Paris, France, 75005
    • Clinique Geoffroy Saint-Hilaire
    • Contact: Arthur ANDRE, MD; Phone Number: 33 06 25 40 60 69; Email: arthur.andre@neurochirurgie.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patient population for minimally invasive lumbar spine surgery

Description

Inclusion Criteria:

• Adult male or female (18 years or older)
• 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:

• Patient with a contraindication to spinal anaesthesia
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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	Procedure: Minimally invasive surgery; Classic Minimally invasive surgery of the lumbar spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index improvement	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	Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain	The intensity of the pain will be assessed using a simple numerical scale (ENS) graduated from 0 (no pain) to 10 (worst pain imaginable).	Day 1
Post-operative pain	The intensity of the pain will be assessed using a simple numerical scale (ENS) graduated from 0 (no pain) to 10 (worst pain imaginable).	Month 1
Consumption of level I, II and II analgesics	Consumption of level I, II and II analgesics. Count of treatments	Day 1
Consumption of level I, II and II analgesics	Consumption of level I, II and II analgesics	Month 1
Pain-free walking perimeter	Measurement in meters of the distance the patient travels until he/she is forced to stop due to pain	Month 1
Evolution of Hospital Anxiety and Depression (HAD) scale score and sub-scores	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).	Month 1
Duration of intervention	Duration of the surgery in hours	Day 1
Length of hospital stay	Length of hospital stay in days	Month 1
Adverse events related to surgery	All adverse events related to surgery will be collected and compared in the 2 groups	Month 1
Visual Analogue Scale overall patient satisfaction	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).	Month 1

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: Arthur ANDRE, MD, Clinique Geoffroy Saint-Hilaire

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020-A02669-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No