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

Fusion of Spine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04891432
• Other study ID #: 2101-142-1191
• Status: Recruiting
• Start date: April 8, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: Chi Heon Kim, MD
• Phone: +82-2-2072-3398
• Email: chiheon1[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fusion of Spine
• Sympathetic Nervous System

Intervention

Procedure:
• Lateral lumbar interbody fusion
oblique lumbar interbody fusion or direct lateral interbody fusion

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Korea

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Other complications	the number of patients with any other complication such as Injury of vascular structure, ureter, peritoneum, or bowel.	Postoperative 6 month