Enhanced Recovery After Surgery in Oblique Lumbar Interbody Fusion
A Prospective, Randomized Controlled Trial Comparing the Outcomes of an Enhanced Recovery After Surgery (ERAS) Program With Non-ERAS Care in Patients Undergoing Oblique Lumbar Interbody Fusion (OLIF)
1 other identifier
interventional
38
1 country
1
Brief Summary
This study is a randomized controlled non-inferiority trial designed to evaluate the impact of implementing the 'Early Recovery After Surgery Clinical Pathway (ERAS CP)' on patient-reported pain levels at the time of discharge following Oblique Lumbar Interbody Fusion (OLIF) surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2023
CompletedStudy Start
First participant enrolled
July 12, 2023
CompletedFirst Posted
Study publicly available on registry
July 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedApril 19, 2024
April 1, 2024
7 months
June 22, 2023
April 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Numeric Rating Scale for back pain and leg pain
Pain intensity will be recorded on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the maximum pain imaginable.
1 day at discharge
Secondary Outcomes (10)
First ambulation time
about postoperative 0~1 day (ex. 4 hours after surgery, 18 hours after surgery)
First self-urination time
about postoperative 0~1 day (ex. 4 hours after surgery, 18 hours after surgery)
Numeric Rating Scale for back pain and leg pain during inhospital status
Daily measurement through the hospitalization period for surgery(ex. at postoperative 1day, at postoperative 2day), Postoperative 1-month
Total analgesic consumption
Daily measurement through the hospitalization period for surgery(ex. at postoperative 1 day, at postoperative 3 day)
Patient satisfaction scale
1 day at discharge, Postoperative 1-month
- +5 more secondary outcomes
Study Arms (2)
ERAS group
EXPERIMENTALThe experimental group will be implemented with the ERAS Clinical Pathway (ERAS CP)
Control group
NO INTERVENTIONThe control group will not be implemented with the ERAS CP
Interventions
In the ERAS CP group, the components of the ERAS are protocolized and implemented as a clinical pathway
Eligibility Criteria
You may qualify if:
- Lumbar degenerative disease, requiring interbody fusion of 1-2 segments between L2 and S1
- Capability of independent (or assisted) ambulation for at least 30 minutes with
- Taking intermittent breaks
- Enduring any discomfort
- Voluntary informed consent to participate in the study.
You may not qualify if:
- Previous history of lumbar interbody fusion
- Manual Muscle Testing grade 3 or below
- Neuropsychiatric disorders such as major depressive disorder
- Musculoskeletal disorders other than lumbar degenerative diseases (inflammatory, myopathic, infections, etc.)
- Diagnosis of malignant neoplasm
- Refusal to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Korea, 03080, South Korea
Related Publications (4)
Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
PMID: 28097305BACKGROUNDDebono B, Wainwright TW, Wang MY, Sigmundsson FG, Yang MMH, Smid-Nanninga H, Bonnal A, Le Huec JC, Fawcett WJ, Ljungqvist O, Lonjon G, de Boer HD. Consensus statement for perioperative care in lumbar spinal fusion: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Spine J. 2021 May;21(5):729-752. doi: 10.1016/j.spinee.2021.01.001. Epub 2021 Jan 12.
PMID: 33444664BACKGROUNDPorche K, Yan S, Mohamed B, Garvan C, Samra R, Melnick K, Vaziri S, Seubert C, Decker M, Polifka A, Hoh DJ. Enhanced recovery after surgery (ERAS) improves return of physiological function in frail patients undergoing one- to two-level TLIFs: an observational retrospective cohort study. Spine J. 2022 Sep;22(9):1513-1522. doi: 10.1016/j.spinee.2022.04.007. Epub 2022 Apr 18.
PMID: 35447326RESULTPorche K, Samra R, Melnick K, Brennan M, Vaziri S, Seubert C, Polifka A, Hoh DJ, Mohamed B. Enhanced recovery after surgery (ERAS) for open transforaminal lumbar interbody fusion: a retrospective propensity-matched cohort study. Spine J. 2022 Mar;22(3):399-410. doi: 10.1016/j.spinee.2021.10.007. Epub 2021 Oct 21.
PMID: 34687905RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chi Heon Kim, MD, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 22, 2023
First Posted
July 25, 2023
Study Start
July 12, 2023
Primary Completion
January 30, 2024
Study Completion
February 28, 2024
Last Updated
April 19, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- After analysis
- Access Criteria
- With any reasonable requeset
IPD will be shared after primary analysis