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

Recruiting

• Conditions: Fusion of Spine; Sympathetic Nervous System

• Registration Number: NCT04891432
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2021-04-08
• Study First Submitted: 2021-05-13
• Study First Submitted QC: 2021-05-13
• Study First Posted: 2021-05-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of sympathetic plexus injury	Postoperative day one	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Korea, Republic of