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Preoperative Prevention and Early Rehabilitation for Patients Undergoing Elective Spine Surgery
This study has been completed.
First Received: April 11, 2007   Last Updated: April 12, 2007   History of Changes
Sponsored by: Rigshospitalet, Denmark
Information provided by: Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00459966
  Purpose

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
Spine Surgery
Procedure: Preoperative rehabilitation

MedlinePlus related topics: Rehabilitation Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety Study

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • hospital discharge

Estimated Enrollment: 60
Study Start Date: February 2005
Study Completion Date: November 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: - Degenerative lumbar disease

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459966

Locations
Denmark
Head-Ortho-Centre, Anesthesiology Department, Rigshospitalet,
Copenhagen, Denmark, dk-2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Per Rotboell Nielsen, MD uaffiliatation
  More Information

No publications provided

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

ClinicalTrials.gov processed this record on May 07, 2009