Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT04962256
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2021-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ERAS in Posterior Approach of Cervical Spine Operation
Sponsor:
Peking University Third Hospital
Organization:
Study Overview
Official Title:
The Application of Enhanced Recovery After Surgery (ERAS) During the Perioperative Period of Patients With Posterior Approach of Cervical Spine Operation: a Mixed Methods Study
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Enhanced recovery after surgery (ERAS) strategy has been used in the patient management of different diseases. This study aims to evaluate the effectiveness of ERAS in the perioperative period of posterior approach of cervical spine operation among patients with CSM.
Detailed Description:
Enhanced recovery after surgery (ERAS) strategy has been used in the patient management of different diseases, but up to now, few effort has been done to evaluate the effectiveness of ERAS in patients perioperative management of cervical spine surgery. As a interdisciplinary cooperation system, either qualitative or quantitative method alone can not completely reflect the function of ERAS. Mixed model research (MMR) is a appropriate method to evaluate a complex system, but it has not been used in ERAS evaluation. This study aims to evaluate the effectiveness of ERAS in the perioperative period of posterior approach of cervical spine operation among patients with CSM using MMR, including the retrospective quantitative part and prospective qualitative part. In the retrospective part, we will collect the data of length of stay, VAS scores, mJOA scores and SF-36 scores to compare the difference between ERAS group and regular group. In the prospective part, we will collect the data from the focus group meetings and personal interviews of patients, to verify that ERAS has the ability to improve the postoperative outcomes, while maintain an equal surgical effect.
Study Oversight
Has Oversight DMC:
True
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?: