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Sponsored by: |
Rigshospitalet, Denmark |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00459966 |
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.
Condition | Intervention |
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Spine Surgery |
Procedure: Preoperative rehabilitation |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety Study |
Estimated Enrollment: | 60 |
Study Start Date: | February 2005 |
Study Completion Date: | November 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Degenerative lumbar disease
Denmark | |
Head-Ortho-Centre, Anesthesiology Department, Rigshospitalet, | |
Copenhagen, Denmark, dk-2100 |
Principal Investigator: | Per Rotboell Nielsen, MD | uaffiliatation |
Study ID Numbers: | 01-041/03 |
Study First Received: | April 11, 2007 |
Last Updated: | April 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00459966 History of Changes |
Health Authority: | Denmark: National Board of Health |