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

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Terminated

Conditions

Spine Surgery

Treatments

Procedure: ERAS

Procedure: Minimally invasive surgery

Study type

Observational

Funder types

Other

Identifiers

NCT05015036

2020-A02669-30

Details and patient eligibility

About

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).

Full 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

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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