Preoperative Prevention and Early Rehabilitation for Patients Undergoing Elective Spine Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spine Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Preoperative rehabilitation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Degenerative lumbar disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Per Rotboell Nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

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Locations

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Head-Ortho-Centre, Anesthesiology Department, Rigshospitalet,

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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01-041/03

Identifier Type: -

Identifier Source: org_study_id