Enhanced Recovery After Surgery in Oblique Lumbar Interbody Fusion

April 18, 2024 updated by: Chi Heon Kim, Seoul National University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Korea
      • Seoul, Korea, Korea, Republic of, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Lumbar degenerative disease, requiring interbody fusion of 1-2 segments between L2 and S1

  2. Capability of independent (or assisted) ambulation for at least 30 minutes with

    1. Taking intermittent breaks
    2. Enduring any discomfort
  3. Voluntary informed consent to participate in the study.

Exclusion Criteria:

  1. Previous history of lumbar interbody fusion
  2. Manual Muscle Testing grade 3 or below
  3. Neuropsychiatric disorders such as major depressive disorder
  4. Musculoskeletal disorders other than lumbar degenerative diseases (inflammatory, myopathic, infections, etc.)
  5. Diagnosis of malignant neoplasm
  6. Refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERAS group
The experimental group will be implemented with the ERAS Clinical Pathway (ERAS CP)
Behavioral: Enhanced Recovery After Surgery program for Oblique Lumbar Interbody Fusion
In the ERAS CP group, the components of the ERAS are protocolized and implemented as a clinical pathway
No Intervention: Control group
The control group will not be implemented with the ERAS CP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day at discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First ambulation time
Time Frame: about postoperative 0~1 day (ex. 4 hours after surgery, 18 hours after surgery)
The time at which a patient first began ambulation after returning to the ward from the operating room
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)
The time at which self-voiding was first initiated after the removal of foley catheter
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
Pain intensity will be recorded on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the maximum pain imaginable.
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)
Total dose analgesic used during inhospital status
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
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.
1 day at discharge, Postoperative 1-month
Rate of complication related to surgery
Time Frame: through study completion, an average of 6 month
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.
through study completion, an average of 6 month
Rate of medical complication
Time Frame: through study completion, an average of 6 month
We examine postoperative internal medicine complications. These complications encompass cardiovascular issues, gastrointestinal disturbances, non-surgical site infections, renal problems, and electrolyte abnormalities.
through study completion, an average of 6 month
30-day readmission
Time Frame: upto postoperative 30 days
Any 30-day readmission after surgery
upto postoperative 30 days
medial cost
Time Frame: postoperative 1-month
The total medical cost incurred during the in-hospital stay for the surgery will be calculated
postoperative 1-month
length of hospital stay
Time Frame: postoperative 1-month
length of the hospitalization days
postoperative 1-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Armed Forces Capital Hospital, Republic of Korea
Medical Research Collaborating Center, Seoul, Korea

Investigators

  • Principal Investigator: Chi Heon Kim, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2023

Primary Completion (Actual)

January 30, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

July 23, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2305-085-1423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared after primary analysis

IPD Sharing Time Frame

After analysis

IPD Sharing Access Criteria

With any reasonable requeset

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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