Spine SurgeryERAMISNCT05015036
Evaluation of an Enhanced Recovery Protocol After Minimally Invasive Lumbar Surgery.
An observational study of Spine Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Surgery
- What is being tested?
- ERAS and Minimally invasive surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2022to 7 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patient population for minimally invasive lumbar spine surgery
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Conditions
- Spine Surgery
- Being tested
- ERAS, Minimally invasive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERASProcedure or surgery
Minimally invasive surgery of the lumbar spine with Enhanced Recovery After Surgery (ERAS)
Minimally invasive surgeryProcedure or surgery
Classic Minimally invasive surgery of the lumbar spine
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive surgery of the lumbar spine with ERAS | Minimally invasive surgery of the lumbar spine with Enhanced Recovery After Surgery (ERAS) Receives: Procedure: ERAS | |
| Minimally invasive surgery of the lumbar spine | Minimally invasive surgery of the lumbar spine Receives: Procedure: Minimally invasive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 1
Secondary outcomes (10)
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).
Measured: 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).
Measured: Month 1
Consumption of level I, II and II analgesics
Consumption of level I, II and II analgesics. Count of treatments
Measured: Day 1
Consumption of level I, II and II analgesics
Consumption of level I, II and II analgesics
Measured: 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
Measured: 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).
Measured: Month 1
Duration of intervention
Duration of the surgery in hours
Measured: Day 1
Length of hospital stay
Length of hospital stay in days
Measured: Month 1
Adverse events related to surgery
All adverse events related to surgery will be collected and compared in the 2 groups
Measured: 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).
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start28 Feb 2022
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur ANDRE, MD, Principal investigator, Clinique Geoffroy Saint-Hilaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015036
- Sponsor's protocol ID
- 2020-A02669-30
- Acronym
- ERAMIS
- Status last verified
- Jul 2024
- First submitted
- 16 Aug 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Enhanced Recovery Protocol After Minimally Invasive Lumbar Surgery.
- ClinicalTrials.gov ID
- NCT05015036
- Acronym / sponsor ID
- ERAMIS / 2020-A02669-30
- Conditions
- Spine Surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 100 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive surgery of the lumbar spine with ERAS | – | Procedure: ERASMinimally invasive surgery of the lumbar spine with Enhanced Recovery After Surgery (ERAS) |
| Minimally invasive surgery of the lumbar spine | – | Procedure: Minimally invasive surgeryMinimally invasive surgery of the lumbar spine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patient population for minimally invasive lumbar spine surgery
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERASMinimally invasive surgery of the lumbar spine with Enhanced Recovery After Surgery (ERAS) | Procedure or surgery | Minimally invasive surgery of the lumbar spine with ERAS |
| Minimally invasive surgeryClassic Minimally invasive surgery of the lumbar spine | Procedure or surgery | Minimally invasive surgery of the lumbar spine |
Primary outcome
Oswestry Disability Index improvement
Time frame: 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
10 secondary outcomes
Post-operative pain
Time frame: Day 1
Post-operative pain
Time frame: Month 1
Consumption of level I, II and II analgesics
Time frame: Day 1
Consumption of level I, II and II analgesics
Time frame: Month 1
Pain-free walking perimeter
Time frame: Month 1
Evolution of Hospital Anxiety and Depression (HAD) scale score and sub-scores
Time frame: Month 1
Duration of intervention
Time frame: Day 1
Length of hospital stay
Time frame: Month 1
Adverse events related to surgery
Time frame: Month 1
Visual Analogue Scale overall patient satisfaction
Time frame: Month 1
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur ANDRE, MD principal investigator
Clinique Geoffroy Saint-Hilaire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index improvement (time frame: Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.