Clinical trial NCT05015036: Evaluation of an Enhanced Recovery Protocol After Minimally Invasive Lumbar Surgery.
Official title: Evaluation of an Enhanced Recovery Protocol After Minimally Invasive Lumbar Surgery.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spine Surgery
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient population for minimally invasive lumbar spine surgery

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).

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

Eligibility criteria: 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

Primary outcomes:
measure: Oswestry Disability Index improvement
timeFrame: Month 1
Secondary outcomes:
measure: Post-operative pain
timeFrame: Day 1
measure: Post-operative pain
timeFrame: Month 1
measure: Consumption of level I, II and II analgesics
timeFrame: Day 1
measure: Consumption of level I, II and II analgesics
timeFrame: Month 1
measure: Pain-free walking perimeter
timeFrame: Month 1
measure: Evolution of Hospital Anxiety and Depression (HAD) scale score and sub-scores
timeFrame: Month 1
measure: Duration of intervention
timeFrame: Day 1
measure: Length of hospital stay
timeFrame: Month 1
measure: Adverse events related to surgery
timeFrame: Month 1
measure: Visual Analogue Scale overall patient satisfaction
timeFrame: Month 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Geoffroy Saint-Hilaire
Study officials:
affiliation: Clinique Geoffroy Saint-Hilaire
name: Arthur ANDRE, MD
role: PRINCIPAL_INVESTIGATOR
References: