Comparison of Surgical Outcomes Between Pre Sympathetic Plexus and Post Sympathetic Plexus Approach

There would be no difference in the risk of sympathetic plexus damage between the pre sympathetic plexus approach and the post sympathetic plexus approach.

Study Overview

• Status: Recruiting
• Conditions: Fusion of Spine; Sympathetic Nervous System
• Intervention / Treatment: Procedure: Lateral lumbar interbody fusion

Detailed Description

Compare the incidence of sympathetic chain injury between front and back of sympathetic approach in oblique lumbar interbody fusion

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Chi Heon Kim, MD; Phone Number: +82-2-2072-3398; Email: chiheon1@snu.ac.kr

Study Locations

• Korea, Republic of
  • Korea
    • Seoul, Korea, Korea, Republic of, 03080
      • Recruiting
      • Seoul National University Hospital
      • Contact: Seoul National U Hospital; Phone Number: 22072358; Email: chiheon1@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with lumbar degenerative disease

Description

Inclusion Criteria:

• Patients with lumbar degenerative disease needs a lateral lumbar interbody fusion of 1-2 segments between L2 to S1.

Exclusion Criteria:

• Patients who had previously had lumbar surgery
• Patients with muscle weakness of motor grade III or lower
• Patients with neuropsychiatric diseases such as depression
• Patients with musculoskeletal disease, inflammatory musculoskeletal disease, or infection
• Patients with cancerous disease
• Patients who do not want to participate in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of sympathetic plexus injury	The number of patiensts with sympathetic symptom such as edema of the lower extremity, change of skin temperature, pain, or paresthesia without other medical conditions	Postoperative day one

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other complications	the number of patients with any other complication such as Injury of vascular structure, ureter, peritoneum, or bowel.	Postoperative 6 month

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 18, 2021

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

• Other Study ID Numbers: 2101-142-1191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes