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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
History of Changes
  Purpose

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.


Condition
Degenerative Lumbar Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by General Hospital Amstetten:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 72
Study Start Date: May 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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'.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195584

Locations
Austria
General Hospital Amstetten
Amstetten, Austria, 3300
Sponsors and Collaborators
General Hospital Amstetten
Investigators
Principal Investigator: Wolfgang Senker, MD General Hospital Amstetten
  More Information

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

Keywords provided by General Hospital Amstetten:
complication rate in 3 cohorts (BMI < 25, > 25 and > 30)

ClinicalTrials.gov processed this record on May 21, 2013