Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease. A Prospective Long-term Evaluation

Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease. A Prospective Long-term Evaluation.

Being confronted more and more with obese as well as older patients, minimally invasive surgery is said to keep the surgical trauma low. The prospective long-term evaluation is the continuous monitoring of patients undergoing lumbar minimally invasive fusion surgery and analyzing the effect of body mass index (BMI) and wound healing.

Study Overview

• Status: Completed
• Conditions: Degenerative Lumbar Disease

• Study Type: Observational
• Enrollment (Actual): 187

Contacts and Locations

Study Locations

• Austria
  • Amstetten, Austria
    • General Hospital

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 will undergo minimal access surgical technige for degenerative lumbar disease fusion

Description

• All patients who will undergo minimally access surgical technique for degenerative lumbar disease fusion surger
• Patient willing to participate in observational study and who signs patient information and patient consent form
• patient older that 18 years
• all products will be 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 (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'.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Operation related complications	between operation and hospital discharge of patient
Post operative fever	between operation and hospital discharge of patient
Liquor leakage	between operation and hosital discharge of patient

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: December 14, 2010
• First Submitted That Met QC Criteria: December 14, 2010
• First Posted (Estimate): December 15, 2010

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 21, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2-Senker