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.

Study Overview

• Status: Completed
• Conditions: Degenerative Lumbar Disease

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Austria
  • Amstetten, Austria, 3300
    • General Hospital Amstetten

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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'.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Complications in the BMI Groups During Post Operative Hospitalization.	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.	at hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation Duration	Duration of the operation in minutes.	after surgery
Blood Loss	Loss of blood during surgical procedure in milliliters.	after surgery
Number of Spine Segments	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.	peri operative
Drainage	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.	at hospital discharge
Days of Hospitalization	Total time of hospitalization.	at hospital discharge

Collaborators and Investigators

• Sponsor: General Hospital Amstetten
• Investigators: Principal Investigator: Wolfgang Senker, MD, General Hospital Amstetten

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: September 3, 2010
• First Submitted That Met QC Criteria: September 3, 2010
• First Posted (Estimate): September 6, 2010

Study Record Updates

• Last Update Posted (Estimate): April 3, 2015
• Last Update Submitted That Met QC Criteria: March 16, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: complication rate in 3 cohorts (BMI < 25, > 25 and > 30)
• Other Study ID Numbers: 1-Senker