NCT05015036

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Conditions

• Spine Surgery

Interventions

Type	Name	Description
PROCEDURE	ERAS	Minimally invasive surgery of the lumbar spine with Enhanced Recovery After Surgery (ERAS)
PROCEDURE	Minimally invasive surgery	Classic Minimally invasive surgery of the lumbar spine

Timeline

• Start date: 2022-02-28
• Primary completion: 2023-09-07
• Completion: 2023-09-07
• First posted: 2021-08-20
• Last updated: 2024-07-03

Locations

1 site across 1 country: France