Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease

This study has been completed.
Sponsor:
Information provided by:
General Hospital Amstetten
ClinicalTrials.gov Identifier:
NCT01195584
First received: September 3, 2010
Last updated: October 24, 2011
Last verified: March 2010

September 3, 2010
October 24, 2011
May 2010
July 2010   (final data collection date for primary outcome measure)
Postoperative Complications in the BMI Groups During Post Operative Hospitalization. [ Time Frame: at hospital discharge ] [ Designated as safety issue: No ]
Postoperative complications related to the operation within the body mass index groups. A complication is any harmful event occuring during the surgery until hospital discharge.
Not Provided
Complete list of historical versions of study NCT01195584 on ClinicalTrials.gov Archive Site
  • Operation Duration [ Time Frame: after surgery ] [ Designated as safety issue: No ]
    Duration of the operation in minutes.
  • Blood Loss [ Time Frame: after surgery ] [ Designated as safety issue: No ]
    Loss of blood during surgical procedure in milliliters.
  • Number of Spine Segments [ Time Frame: peri operative ] [ Designated as safety issue: No ]
    Number of affected spine segments. One spine segment is defined as 2 vertebral bodies and the intervertebral disc (between the 2 vertebral bodies). For this study the number fo affected spine segments is identical to the number of operated intervertebral discs.
  • Drainage [ Time Frame: at hospital discharge ] [ Designated as safety issue: No ]
    Drainage during hospitalization. The drainage was placed during the surgery and has been removed prior to hospital discharge. The amount of drainage in milliliters has been measured.
  • Days of Hospitalization [ Time Frame: at hospital discharge ] [ Designated as safety issue: No ]
    Total time of hospitalization.
Not Provided
Not Provided
Not Provided
 
Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease
Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease

The study concerns a retrospective analysis of all subjects operated as of 1st Jan 2008 using Minimal Access Surgical Technique (MAST). The study is descriptive in nature and will present the observation of all cumulated patients operated with MAST.

The study data will include the general health information of the subjects prior to surgery, information on the surgery such as OP time, blood loss, and the postoperative wound healing process (until discharge), which is on average the 10th postoperative day.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

All patients who underwent minimal access spinal surgery for degenerative lumbar disease fusion surgery.

Degenerative Lumbar Disease
Not Provided
  • BMI < 25
    Body Mass Index (WHO) established by WHO. BMI < 25 has been defined as 'normal weight'.
  • 25 >= BMI < 30
    Body Mass Index (WHO) established by WHO. BMI >= 25 and < 30 has been defined as 'overweight'.
  • BMI >= 30
    Body Mass Index (WHO) established by WHO. BMI > 30 has been defined as 'obese'.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion and Exclusion Criteria:

  • all patients who underwent minimal access spinal surgery for degenerative lumbar disease fusion surgery
  • patient older than 18 years
  • all products have been used within intended use
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01195584
1-Senker
No
Wolfgang Senker, MD, General Hospital Amstetten
General Hospital Amstetten
Not Provided
Principal Investigator: Wolfgang Senker, MD General Hospital Amstetten
General Hospital Amstetten
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP