Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery (MERAOLIS)

Capital Medical University

Status: Enrolling

Conditions: Lumbar Spondylosis; Lumbar Spinal Stenosis; Lumbar Disc Herniation

Treatments: Other: routine protocol; Other: Modified ERAS protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05854043

xuanwuOLIF

Details and patient eligibility

About

The goal of this randomized clinical trial is to investigate whether modified enhanced recovery after surgery (ERAS) in oblique lumbar interbody fusion (OLIF) can shorten the postoperative hospital stay among patients with lumbar degenerative disease.

The main questions it aims to answer are:

Whether ERAS can shorten the postoperative hospital stay. Whether modified ERAS can improve postoperative functional recovery, improve functional score and pain score, reduce hospitalization costs, improve mental state, and improve abdominal indicators, etc.

Participants will be randomized into modified ERAS group, or control group.

Full description

The main questions it aims to answer are:

Whether ERAS can shorten the postoperative hospital stay. Whether modified ERAS can improve postoperative functional recovery, improve functional score and pain score, reduce hospitalization costs, improve mental state, and improve abdominal indicators, etc.

Participants will be randomized into modified ERAS group, or control group.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-80 years old;
• Lumbar degenerative diseases that meet the indications of fusion surgery;
• Patients who are suitable for OLIF surgery;
• Patients who have actually completed OLIF surgery;
• The number of fusion segments is less than or equal to two;
• There was no basis for serious diseases of brain, lung, kidney and other important organs, and preoperative American Society of Anesthesiologists (ASA) score was I-III;
• Agree to participate in the study and sign the informed consent form.

Exclusion criteria

• Patients undergoing lumbar fusion surgery due to spinal trauma;
• Patients undergoing lumbar fusion surgery due to spinal tumor resection;
• Revision surgery;
• The number of fused segments is more than 2;
• Simultaneous lumbar fusion via other approaches, such as transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF), anterior lumbar interbody fusion (ALIF), etc.;
• Pregnancy or perinatal period;
• Blood system diseases lead to coagulation dysfunction;
• Combined with other diseases, life expectancy less than 2 years;
• Patients is participating in other clinical trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

96 participants in 2 patient groups

ERAS group

Experimental group

Description:

In this group, patients will be treated with modified ERAS protocol.

Treatment:

Other: Modified ERAS protocol

control group

Other group

Description:

In this group, patients will be treated with routine protocol.

Treatment:

Other: routine protocol