Back to resultsModified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery (MERAOLIS)
Primary Purpose
Lumbar Spondylosis, Lumbar Spinal Stenosis, Lumbar Disc Herniation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Modified ERAS protocol
routine protocol
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spondylosis
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.
Sites / Locations
- Xuanwu hospital capital medical universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
ERAS group
control group
Arm Description
In this group, patients will be treated with modified ERAS protocol.
In this group, patients will be treated with routine protocol.
Outcomes
Primary Outcome Measures
Postoperative hospital stay
The length of hospital stay post-operation.
Secondary Outcome Measures
Postoperative functional recovery
Evaluate the functional recovery through 6 Minutes Walk Distance. A longer walk distance indicates better functional recovery.
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.
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.
Postoperative life quality assessment
Postoperative EuroQol-5 Dimensions (EQ-5D) at different time points for life quality assessment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05854043
Brief Title
Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery
Acronym
MERAOLIS
Official Title
Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spondylosis, Lumbar Spinal Stenosis, Lumbar Disc Herniation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ERAS group
Arm Type
Experimental
Arm Description
In this group, patients will be treated with modified ERAS protocol.
Arm Title
control group
Arm Type
Other
Arm Description
In this group, patients will be treated with routine protocol.
Intervention Type
Other
Intervention Name(s)
Modified ERAS protocol
Intervention Description
Modified ERAS protocol for OLIF mainly include perioperative analgesic drug management, operation optimization in the anesthetic management, management of gastrointestinal function, and early mobilization management.
Perioperative analgesic usage:
Nonsteroidal anti-inflammatory drugs (NSAIDs) given when Visual Analogue Scale (VAS)>3. Prehabilitation: Respiratory function exercise; walk at least 200 meters daily. Gastrointestinal function management: Oral lactulose use routinely. Sedation and analgesia: patient status index (PSI) 25-50; analgesia nociception index (ANI) 50-70. Local anesthetic: local infiltration around the psoas muscle. Postop off-bed activity: start mobilization within 24h.
Intervention Type
Other
Intervention Name(s)
routine protocol
Intervention Description
Perioperative analgesic usage: NSAIDs given follow the patients requirement. Prehabilitation: None. Gastrointestinal function management: None. Sedation and analgesia: bispectral index (BIS) 40-60. Local anesthetic: None. Postop off-bed activity: mobilization follow the patients wish.
Primary Outcome Measure Information:
Title
Postoperative hospital stay
Description
The length of hospital stay post-operation.
Time Frame
From the date of surgery to discharge, assessed up to 1 month
Secondary Outcome Measure Information:
Title
Postoperative functional recovery
Description
Evaluate the functional recovery through 6 Minutes Walk Distance. A longer walk distance indicates better functional recovery.
Time Frame
From the date of surgery to discharge, assessed up to 1 month
Title
Postoperative pain score
Description
Postoperative VAS at different time points for pain assessment. From 0-10, 0 indicates no pain, 10 indicates the most severe pain.
Time Frame
From the date of surgery to 1 year post-operation
Title
Postoperative lumbar neurological function assessment
Description
Postoperative Japanese Orthopedics Association (JOA) at different time points for life quality assessment. From 0-29, A lower score indicates more dysfunction.
Time Frame
From the date of surgery to 1 year post-operation
Title
Postoperative life quality assessment
Description
Postoperative EuroQol-5 Dimensions (EQ-5D) at different time points for life quality assessment.
Time Frame
From the date of surgery to 1 year post-operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Zhang, MD
Phone
17610549095
Email
zhanglei@xwhosp.org
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenlei Liu, MD
Email
Zhenlei.liu@xwhosp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Wu, MD
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu hospital capital medical university
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Zhang, MD
Phone
17510549095
Email
zhanglei@xwhosp.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery
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