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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
Results First Received: August 16, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Degenerative Lumbar Disease

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All patients fulfilling in- and exclusion criteria were enrolled into the retrospecitve study. All consecutive 72 patients who signed the patient informed consent were included. Patients were stratified in three groups according to their body mass index (BMI) established by WHO. Enrollment period from January 2009 - August 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BMI < 25 Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
25 <= BMI < 30 Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
BMI >= 30 Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.

Participant Flow:   Overall Study
    BMI < 25     25 <= BMI < 30     BMI >= 30  
STARTED     20     25     27  
COMPLETED     20     25     27  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BMI < 25 Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
25 <= BMI < 30 Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
BMI >= 30 Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.
Total Total of all reporting groups

Baseline Measures
    BMI < 25     25 <= BMI < 30     BMI >= 30     Total  
Number of Participants  
[units: participants]
  20     25     27     72  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     14     9     17     40  
>=65 years     6     16     10     32  
Age  
[units: years]
Mean ± Standard Deviation
  53.5  ± 12.1     67.2  ± 12.7     62.8  ± 11.3     61.8  ± 13.1  
Gender  
[units: participants]
       
Female     9     15     18     42  
Male     11     10     9     30  
Region of Enrollment  
[units: participants]
       
Austria     20     25     27     72  



  Outcome Measures
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1.  Primary:   Postoperative Complications in the BMI Groups During Post Operative Hospitalization.   [ Time Frame: at hospital discharge ]

2.  Secondary:   Operation Duration   [ Time Frame: after surgery ]

3.  Secondary:   Blood Loss   [ Time Frame: after surgery ]

4.  Secondary:   Number of Spine Segments   [ Time Frame: peri operative ]

5.  Secondary:   Drainage   [ Time Frame: at hospital discharge ]

6.  Secondary:   Days of Hospitalization   [ Time Frame: at hospital discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study is retrospective and all patients during the timeframe (who signed the patient informed consent) have been included into the study.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Wolfgang Senker, MD
Organization: General Hospital Amstetten
phone: +43 7472 6040 ext 6611
e-mail: wolfgang.senker@aon.at


No publications provided


Responsible Party: Wolfgang Senker, MD, General Hospital Amstetten
ClinicalTrials.gov Identifier: NCT01195584     History of Changes
Other Study ID Numbers: 1-Senker
Study First Received: September 3, 2010
Results First Received: August 16, 2011
Last Updated: October 24, 2011
Health Authority: Austria: Ethikkommission