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

Spine Surgery Clinical Trial

— ERAMIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05015036
• Other study ID #: 2020-A02669-30
• Status: Not yet recruiting
• Start date: October 2021
• Est. completion date: November 2023

Study information

• Verified date: August 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Arthur ANDRE, MD
• Phone: 06 25 40 60 69
• Email: arthur.andre[@]neurochirurgie.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 302
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spine Surgery

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	Clinique Geoffroy Saint-Hilaire	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Consumption of level I, II and II analgesics	Consumption of level I, II and II analgesics. Count of treatments	Day 1
Secondary	Consumption of level I, II and II analgesics	Consumption of level I, II and II analgesics	Month 1
Secondary	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
Secondary	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
Secondary	Duration of intervention	Duration of the surgery in hours	Day 1
Secondary	Length of hospital stay	Length of hospital stay in days	Month 1
Secondary	Adverse events related to surgery	All adverse events related to surgery will be collected and compared in the 2 groups	Month 1
Secondary	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