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Preoperative Prevention and Early Rehabilitation for Patients Undergoing Elective Spine Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00459966
First Posted: April 13, 2007
Last Update Posted: April 13, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Degenerative lumbar disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00459966     History of Changes
Other Study ID Numbers: 01-041/03
First Submitted: April 11, 2007
First Posted: April 13, 2007
Last Update Posted: April 13, 2007
Last Verified: April 2007