Lumbar SpondylosisMERAOLISNCT05854043
Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery
A study testing Modified ERAS protocol and routine protocol in people with Lumbar Spondylosis and Lumbar Spinal Stenosis, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Spondylosis, Lumbar Spinal Stenosis, Lumbar Disc Herniation
- What is being tested?
- Modified ERAS protocol and routine protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
Zhenlei Liu, MD contact
China1 site, 1 recruiting
- Recruiting
Xuanwu hospital capital medical university
Beijing, Beijing Municipality, 100053
Lei Zhang, MD, 17510549095, zhanglei@xwhosp.org
About this study
Official title: Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery: a Randomised Controlled Trial
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.
Read the 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.
- Being tested
- Modified ERAS protocol, routine protocol
- Medical subject headings
- Spondylosis, Spinal Stenosis, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified ERAS protocolOther
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.
routine protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Experimental | In this group, patients will be treated with modified ERAS protocol. Receives: Other: Modified ERAS protocol |
| control group | Other | In this group, patients will be treated with routine protocol. Receives: Other: routine protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hospital stay
The length of hospital stay post-operation.
Measured: From the date of surgery to discharge, assessed up to 1 month
Secondary outcomes (4)
Postoperative functional recovery
Evaluate the functional recovery through 6 Minutes Walk Distance. A longer walk distance indicates better functional recovery.
Measured: From the date of surgery to discharge, assessed up to 1 month
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.
Measured: From the date of surgery to 1 year post-operation
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.
Measured: From the date of surgery to 1 year post-operation
Postoperative life quality assessment
Postoperative EuroQol-5 Dimensions (EQ-5D) at different time points for life quality assessment.
Measured: From the date of surgery to 1 year post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Apr 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar SpondylosisStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Wu, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854043
- Sponsor's protocol ID
- xuanwuOLIF
- Acronym
- MERAOLIS
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05854043
- Acronym / sponsor ID
- MERAOLIS / xuanwuOLIF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Experimental | Other: Modified ERAS protocolIn this group, patients will be treated with modified ERAS protocol. |
| control group | Other | Other: routine protocolIn this group, patients will be treated with routine protocol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (9 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified ERAS protocolModified 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. | Other | ERAS group |
| routine protocolPerioperative 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. | Other | control group |
Primary outcome
Postoperative hospital stay
Time frame: From the date of surgery to discharge, assessed up to 1 month
The length of hospital stay post-operation.
4 secondary outcomes
Postoperative functional recovery
Time frame: From the date of surgery to discharge, assessed up to 1 month
Postoperative pain score
Time frame: From the date of surgery to 1 year post-operation
Postoperative lumbar neurological function assessment
Time frame: From the date of surgery to 1 year post-operation
Postoperative life quality assessment
Time frame: From the date of surgery to 1 year post-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No
Related trials for Lumbar Spondylosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Recruiting
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Lumbar Spine Degeneration, Lumbar Spine Instability
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Not yet recruiting
Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves
Lumbar Spondylosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenlei Liu, MD contact
Hao Wu, MD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified ERAS protocol and routine protocol in people with Lumbar Spondylosis and Lumbar Spinal Stenosis, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Zhang, MD (17610549095, zhanglei@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative hospital stay (time frame: From the date of surgery to discharge, assessed up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.