Enhanced Recovery After SurgeryNCT05959343
Enhanced Recovery After Surgery in Oblique Lumbar Interbody Fusion
A study testing Enhanced Recovery After Surgery program for Oblique Lumbar Interbody Fusion in people with Enhanced Recovery After Surgery and Spinal Fusion, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Enhanced Recovery After Surgery, Spinal Fusion, Lumbar Spinal Stenosis
- What is being tested?
- Enhanced Recovery After Surgery program for Oblique Lumbar Interbody Fusion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jul 2023to 28 Feb 2024
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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
Read the detailed description
Currently, the effectiveness of the ERAS has been widely confirmed in patients undergoing colorectal resection, and it has been verified to reduce length of hospital stay and complications. However, the ERAS protocol for lumbar fusion surgery is based on a few retrospective studies and remains a consensus statement. Recent retrospective studies targeting patients undergoing lumbar fusion surgery reported that implementing ERAS could accelerate post-operative functional recovery and reduce hospital stay. However, there is still a lack of high-quality evidence based on prospective studies.
Lumbar fusion surgery is known for potentially leading to severe postoperative pain, which poses challenges in consistently applying ERAS components, such as early ambulation or active oral feeding, after surgery. In light of this, the present study aims to validate the non-inferiority of pain levels at discharge within the ERAS group and to reconfirm the effects of ERAS as observed in retrospective studies.
Patients admitted for OLIF will be consecutively screened for eligibility. A computer-generated block randomization will be executed at a 1:1 ratio. In the ERAS group, patients will receive comprehensive education about the treatment process, and a clinical pathway that includes active ambulation and pain control will be protocolized and implemented. Should non-inferiority be demonstrated in both intent-to-treat and per-protocol analyses, non-inferiority will be declared.
- Conditions
- Enhanced Recovery After Surgery, Spinal Fusion, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis
- Being tested
- Enhanced Recovery After Surgery program for Oblique Lumbar Interbody Fusion
- Medical subject headings
- Spinal Stenosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgery program for Oblique Lumbar Interbody FusionBehavioural
In the ERAS CP group, the components of the ERAS are protocolized and implemented as a clinical pathway
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Experimental | The experimental group will be implemented with the ERAS Clinical Pathway (ERAS CP) Receives: Behavioral: Enhanced Recovery After Surgery program for Oblique Lumbar Interbody Fusion |
| Control group | No intervention | The control group will not be implemented with the ERAS CP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day at discharge
Secondary outcomes (10)
First ambulation time
The time at which a patient first began ambulation after returning to the ward from the operating room
Measured: about postoperative 0~1 day (ex. 4 hours after surgery, 18 hours after surgery)
First self-urination time
The time at which self-voiding was first initiated after the removal of foley catheter
Measured: 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
Pain intensity will be recorded on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the maximum pain imaginable.
Measured: Daily measurement through the hospitalization period for surgery(ex. at postoperative 1day, at postoperative 2day), Postoperative 1-month
Total analgesic consumption
Total dose analgesic used during inhospital status
Measured: Daily measurement through the hospitalization period for surgery(ex. at postoperative 1 day, at postoperative 3 day)
Patient satisfaction scale
We survey patients using a 4-point scale to gauge their overall satisfaction with the treatment process. On this scale, 4 represents 'very satisfied,' 3 is 'satisfied,' 2 is 'dissatisfied,' and 1 indicates 'very dissatisfied.
Measured: 1 day at discharge, Postoperative 1-month
Rate of complication related to surgery
We investigate complications related to the surgery. Such complications include vascular damage, ureteral injury, abdominal wall injury, herniation, sympathetic nerve chain damage, leg weakness, and surgical wound infections.
Measured: through study completion, an average of 6 month
Rate of medical complication
We examine postoperative internal medicine complications. These complications encompass cardiovascular issues, gastrointestinal disturbances, non-surgical site infections, renal problems, and electrolyte abnormalities.
Measured: through study completion, an average of 6 month
30-day readmission
Any 30-day readmission after surgery
Measured: upto postoperative 30 days
medial cost
The total medical cost incurred during the in-hospital stay for the surgery will be calculated
Measured: postoperative 1-month
length of hospital stay
length of the hospitalization days
Measured: postoperative 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start12 Jul 2023
- Primary completion30 Jan 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Enhanced Recovery After SurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Collaborating Center, Seoul, Korea, Armed Forces Capital Hospital, Republic of Korea
- Responsible party
- Principal investigator, Chi Heon Kim, Seoul National University Hospital
- Investigators
- Chi Heon Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959343
- Sponsor's protocol ID
- H-2305-085-1423
- Status last verified
- Apr 2024
- First submitted
- 22 Jun 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared after primary analysis
Publications
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.
PubMed 28097305Debono 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.
PubMed 33444664Porche 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.
PubMed 35447326Porche 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.
PubMed 34687905
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05959343
- Acronym / sponsor ID
- H-2305-085-1423
- Conditions
- Enhanced Recovery After Surgery, Spinal Fusion, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Medical Research Collaborating Center, Seoul, Korea, Armed Forces Capital Hospital, Republic of Korea
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 25 Jul 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.
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
Detailed description
Currently, the effectiveness of the ERAS has been widely confirmed in patients undergoing colorectal resection, and it has been verified to reduce length of hospital stay and complications. However, the ERAS protocol for lumbar fusion surgery is based on a few retrospective studies and remains a consensus statement. Recent retrospective studies targeting patients undergoing lumbar fusion surgery reported that implementing ERAS could accelerate post-operative functional recovery and reduce hospital stay. However, there is still a lack of high-quality evidence based on prospective studies.
Lumbar fusion surgery is known for potentially leading to severe postoperative pain, which poses challenges in consistently applying ERAS components, such as early ambulation or active oral feeding, after surgery. In light of this, the present study aims to validate the non-inferiority of pain levels at discharge within the ERAS group and to reconfirm the effects of ERAS as observed in retrospective studies.
Patients admitted for OLIF will be consecutively screened for eligibility. A computer-generated block randomization will be executed at a 1:1 ratio. In the ERAS group, patients will receive comprehensive education about the treatment process, and a clinical pathway that includes active ambulation and pain control will be protocolized and implemented. Should non-inferiority be demonstrated in both intent-to-treat and per-protocol analyses, non-inferiority will be declared.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Experimental | Behavioral: Enhanced Recovery After Surgery program for Oblique Lumbar Interbody FusionThe experimental group will be implemented with the ERAS Clinical Pathway (ERAS CP) |
| Control group | No intervention | –The control group will not be implemented with the ERAS CP |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Voluntary informed consent to participate in the study.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Enhanced Recovery After Surgery program for Oblique Lumbar Interbody FusionIn the ERAS CP group, the components of the ERAS are protocolized and implemented as a clinical pathway | Behavioural | ERAS group |
Primary outcome
Numeric Rating Scale for back pain and leg pain
Time frame: 1 day at discharge
Pain intensity will be recorded on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the maximum pain imaginable.
10 secondary outcomes
First ambulation time
Time frame: about postoperative 0~1 day (ex. 4 hours after surgery, 18 hours after surgery)
First self-urination time
Time frame: 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
Time frame: Daily measurement through the hospitalization period for surgery(ex. at postoperative 1day, at postoperative 2day), Postoperative 1-month
Total analgesic consumption
Time frame: Daily measurement through the hospitalization period for surgery(ex. at postoperative 1 day, at postoperative 3 day)
Patient satisfaction scale
Time frame: 1 day at discharge, Postoperative 1-month
Rate of complication related to surgery
Time frame: through study completion, an average of 6 month
Rate of medical complication
Time frame: through study completion, an average of 6 month
30-day readmission
Time frame: upto postoperative 30 days
medial cost
Time frame: postoperative 1-month
length of hospital stay
Time frame: postoperative 1-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 28097305Ljungqvist 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.
- Background: PubMed 33444664Debono 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.
- Results publication: PubMed 35447326Porche 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.
- Results publication: PubMed 34687905Porche 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.
- Individual participant dataSharing planned: Yes. IPD will be shared after primary analysis
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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.
Chi Heon Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery program for Oblique Lumbar Interbody Fusion in people with Enhanced Recovery After Surgery and Spinal Fusion, run by Seoul National University Hospital at 1 site in South Korea.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 19 Apr 2024. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale for back pain and leg pain (time frame: 1 day at discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05959343, which also lists 4 linked publications.
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 19 Apr 2024.