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Clinical Trials/NCT05854043
NCT05854043
Recruiting
Not Applicable

Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery: a Randomised Controlled Trial

Xuanwu Hospital, Beijing1 site in 1 country96 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbar Spondylosis
Sponsor
Xuanwu Hospital, Beijing
Enrollment
96
Locations
1
Primary Endpoint
Postoperative hospital stay
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this randomized clinical trial is to investigate whether modified enhanced recovery after surgery (ERAS) in oblique lumbar interbody fusion (OLIF) can shorten the postoperative hospital stay among patients with lumbar degenerative disease.

The main questions it aims to answer are:

Whether ERAS can shorten the postoperative hospital stay. Whether modified ERAS can improve postoperative functional recovery, improve functional score and pain score, reduce hospitalization costs, improve mental state, and improve abdominal indicators, etc.

Participants will be randomized into modified ERAS group, or control group.

Detailed Description

The main questions it aims to answer are: Whether ERAS can shorten the postoperative hospital stay. Whether modified ERAS can improve postoperative functional recovery, improve functional score and pain score, reduce hospitalization costs, improve mental state, and improve abdominal indicators, etc. Participants will be randomized into modified ERAS group, or control group.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
April 1, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 18-80 years old;
  • Lumbar degenerative diseases that meet the indications of fusion surgery;
  • Patients who are suitable for OLIF surgery;
  • Patients who have actually completed OLIF surgery;
  • The number of fusion segments is less than or equal to two;
  • There was no basis for serious diseases of brain, lung, kidney and other important organs, and preoperative American Society of Anesthesiologists (ASA) score was I-III;
  • Agree to participate in the study and sign the informed consent form.

Exclusion Criteria

  • Patients undergoing lumbar fusion surgery due to spinal trauma;
  • Patients undergoing lumbar fusion surgery due to spinal tumor resection;
  • Revision surgery;
  • The number of fused segments is more than 2;
  • Simultaneous lumbar fusion via other approaches, such as transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF), anterior lumbar interbody fusion (ALIF), etc.;
  • Pregnancy or perinatal period;
  • Blood system diseases lead to coagulation dysfunction;
  • Combined with other diseases, life expectancy less than 2 years;
  • Patients is participating in other clinical trials.

Outcomes

Primary Outcomes

Postoperative hospital stay

Time Frame: From the date of surgery to discharge, assessed up to 1 month

The length of hospital stay post-operation.

Secondary Outcomes

  • Postoperative functional recovery(From the date of surgery to discharge, assessed up to 1 month)
  • Postoperative pain score(From the date of surgery to 1 year post-operation)
  • Postoperative life quality assessment(From the date of surgery to 1 year post-operation)
  • Postoperative lumbar neurological function assessment(From the date of surgery to 1 year post-operation)

Study Sites (1)

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