Clinical trial NCT05854043: Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery
Official title: Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Spondylosis
Lumbar Spinal Stenosis
Lumbar Disc Herniation
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative hospital stay
timeFrame: From the date of surgery to discharge, assessed up to 1 month
Secondary outcomes:
measure: Postoperative functional recovery
timeFrame: From the date of surgery to discharge, assessed up to 1 month
measure: Postoperative pain score
timeFrame: From the date of surgery to 1 year post-operation
measure: Postoperative lumbar neurological function assessment
timeFrame: From the date of surgery to 1 year post-operation
measure: Postoperative life quality assessment
timeFrame: From the date of surgery to 1 year post-operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu hospital capital medical university
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Hao Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: