Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-27 @ 3:33 PM
Study NCT ID:
NCT00459966
Status:
COMPLETED
Last Update Posted:
2007-04-13
First Post:
2007-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Prevention and Early Rehabilitation for Patients Undergoing Elective Spine Surgery
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-04
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:
Aim: The aim is to evaluate the outcome after spine surgery when using an integrated program that combined preoperative prevention and early postoperative rehabilitation compared to the routine procedures.
Outcome measurements: Postoperative hospital stay, complications, function, pain, and patient satisfaction.
Method: 60 patients scheduled for surgery for degenerative lumbar disease. The control group followed the routines in the department. The intervention group followed the integrated program consisting of preoperative prevention.
Outcome measurements: Postoperative hospital stay, complications, function, pain, and patient satisfaction.
Method: 60 patients scheduled for surgery for degenerative lumbar disease. The control group followed the routines in the department. The intervention group followed the integrated program consisting of preoperative prevention.
Detailed Description:
Introduction: An increasing number of patients undergo surgery for degenerative spine disease, which is, however, related to a significant development of postoperative complications. Evidence has been gathered for other surgical procedures about improved outcome after early rehabilitation programs (fast track surgery), preoperative smoking and alcohol cessation programs, respectively. Hitherto, no studies have been published concerning a combined program of the preoperative prevention programs and fast track surgery.
Aim: The aim is to evaluate the outcome after spine surgery when using an integrated program that combined preoperative prevention and early postoperative rehabilitation compared to the routine procedures.
Outcome measurements: Postoperative hospital stay, complications, function, pain, and patient satisfaction.
Method: 60 patients scheduled for surgery for degenerative lumbar disease were computer-randomized to intervention. The control group followed the routines in the department. The intervention group followed the integrated program consisting of preoperative prevention, which began 2 months prior to the operation: an exercise program designed to strengthen the muscles of the spine, and optimization of the analgetic treatment. Smokers and harmful drinkers were offered cessation intervention. The day before surgery all had enteral protein supplement.
Early postoperative rehabilitation included balanced pain therapy, including self-administered epidural analgesia, intensified mobilization immediately after surgery and enteral protein supplement.
Aim: The aim is to evaluate the outcome after spine surgery when using an integrated program that combined preoperative prevention and early postoperative rehabilitation compared to the routine procedures.
Outcome measurements: Postoperative hospital stay, complications, function, pain, and patient satisfaction.
Method: 60 patients scheduled for surgery for degenerative lumbar disease were computer-randomized to intervention. The control group followed the routines in the department. The intervention group followed the integrated program consisting of preoperative prevention, which began 2 months prior to the operation: an exercise program designed to strengthen the muscles of the spine, and optimization of the analgetic treatment. Smokers and harmful drinkers were offered cessation intervention. The day before surgery all had enteral protein supplement.
Early postoperative rehabilitation included balanced pain therapy, including self-administered epidural analgesia, intensified mobilization immediately after surgery and enteral protein supplement.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: