Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-25 @ 6:43 PM
Study NCT ID:
NCT04538092
Status:
TERMINATED
Last Update Posted:
2023-11-18
First Post:
2020-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complex Spine Enhanced Recovery After Surgery (ERAS)
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Single Institution Prospective Analysis of an Enhanced Recovery After Complex Spine Surgery Protocol
Status:
TERMINATED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI moved to different institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the field of Adult Spinal Deformity (ASD), there are currently no standardized protocols for preoperative, intraoperative or post-operative care. New standards are being created for minimally invasive spine surgery within orthopedics and some neurosurgical centers. This study will evaluate the efficacy of an Enhanced Recovery After Surgery protocol for complex spine surgery performed for the treatment of ASD.
Detailed Description:
Purpose : In the field of Adult Spinal Deformity (ASD), there are currently no standardized protocols for preoperative, intraoperative or post-operative care. New standards are being created for minimally invasive spine surgery within orthopedics and some neurosurgical centers. This study will evaluate the efficacy of an Enhanced Recovery After Surgery protocol for complex spine surgery performed for the treatment of ASD.
Participants : Patients undergoing surgery aimed at treating adult spinal deformity are the subject of this research. This population was chosen as these procedures are often associated with prolonged length of stay (LOS), high post-operative narcotic use, and often require complex post-operative discharge planning.
Procedures : Patients undergoing surgery to address the complications of ASD present a unique challenge in that this patient population is diverse, and there are multiple operative procedures available to treat the same condition. Given that there are currently no accepted or recommended Enhanced Recovery After Surgery protocols for complex spine procedures, the investigators have developed an ERAS protocol at the University of North Carolina (UNC) in collaboration with the anesthesia department for the support of complex surgical patients.
Hypothesis: Implementing a multi-modal enhanced recovery after complex spine surgery protocol will improve patient measured outcomes and patient functional outcomes leading to a statistically significant reduction in LOS, post-operative pain, complication rate, cost.
Participants : Patients undergoing surgery aimed at treating adult spinal deformity are the subject of this research. This population was chosen as these procedures are often associated with prolonged length of stay (LOS), high post-operative narcotic use, and often require complex post-operative discharge planning.
Procedures : Patients undergoing surgery to address the complications of ASD present a unique challenge in that this patient population is diverse, and there are multiple operative procedures available to treat the same condition. Given that there are currently no accepted or recommended Enhanced Recovery After Surgery protocols for complex spine procedures, the investigators have developed an ERAS protocol at the University of North Carolina (UNC) in collaboration with the anesthesia department for the support of complex surgical patients.
Hypothesis: Implementing a multi-modal enhanced recovery after complex spine surgery protocol will improve patient measured outcomes and patient functional outcomes leading to a statistically significant reduction in LOS, post-operative pain, complication rate, cost.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: