Lumbar Spinal Stenosis Clinical Trial
— MERAOLISOfficial title:
Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery: a Randomised Controlled Trial
NCT number | NCT05854043 |
Other study ID # | xuanwuOLIF |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2023 |
Est. completion date | April 1, 2025 |
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.
Status | Recruiting |
Enrollment | 96 |
Est. completion date | April 1, 2025 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Xuanwu hospital capital medical university | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative hospital stay | The length of hospital stay post-operation. | From the date of surgery to discharge, assessed up to 1 month | |
Secondary | Postoperative functional recovery | Evaluate the functional recovery through 6 Minutes Walk Distance. A longer walk distance indicates better functional recovery. | From the date of surgery to discharge, assessed up to 1 month | |
Secondary | Postoperative pain score | Postoperative VAS at different time points for pain assessment. From 0-10, 0 indicates no pain, 10 indicates the most severe pain. | From the date of surgery to 1 year post-operation | |
Secondary | Postoperative lumbar neurological function assessment | Postoperative Japanese Orthopedics Association (JOA) at different time points for life quality assessment. From 0-29, A lower score indicates more dysfunction. | From the date of surgery to 1 year post-operation | |
Secondary | Postoperative life quality assessment | Postoperative EuroQol-5 Dimensions (EQ-5D) at different time points for life quality assessment. | From the date of surgery to 1 year post-operation |
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