Unscheduled Hospital Readmission After Crenel Lateral Interbody Fusion

Factors and Experiences Associated with Unscheduled Hospital Readmission After Crenel Lateral Interbody Fusion

The goal of this observational study is to learn about the readmission related to Crenel Lateral Interbody Fusion (CLIF). The main question it aims to answer is:

What are the risk factors for readmission after CLIF surgery?

Study Overview

• Status: Completed
• Conditions: Spine Degeneration
• Intervention / Treatment: Procedure: Crenel lateral interbody fusion plus second stage surgery; Procedure: Crenel Lateral Interbody Fusion

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients (>18 years old) with spinal degeneration undergoing CLIF surgery, including both unscheduled and scheduled readmissions.

Description

Inclusion Criteria:

• Patients with spinal degeneration undergoing CLIF surgery

Exclusion Criteria:

• Under the age of 18

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Unscheduled readimission; Unscheduled readimission after CLIF	Procedure: Crenel lateral interbody fusion plus second stage surgery; The patient was first admitted to undergo CLIF surgery and was discharged after the operation. The patient will return to the hospital for a second surgery at the scheduled time.
Scheduled readimission; Scheduled readimission after CLIF	Procedure: Crenel Lateral Interbody Fusion; The Crenel Lateral Interbody Fusion (CLIF) is a surgical technique developed by the Department of Spine Surgery at the Second Affiliated Hospital of Zhejiang University School of Medicine. Building on the traditional Lateral Lumbar Interbody Fusion technique, this series of technical improvements overcomes the shortcomings of previous surgical methods, enhancing the safety, operability, and effectiveness of the surgery while reducing complications.; Other Names: Lateral Lumbar Interbody Fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unscheduled readmission	Unscheduled readmission refers to a patient who was unplanned or unexpected return to the hospital after CLIF discharged from a previous hospitalization.	1 year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Actual): July 25, 2024
• Study Completion (Actual): August 2, 2024

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Spine Degeneration
• Other Study ID Numbers: 2024-0165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

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.: No