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

NCT01195584 | Completed Results

• 1 other identifier: 1-Senker
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Degenerative Lumbar Disease

Keywords

complication rate in 3 cohorts (BMI < 25, > 25 and > 30)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Operation Duration

  after surgery

• Blood Loss

  after surgery

• Number of Spine Segments

  peri operative

• Drainage

  at hospital discharge

• Days of Hospitalization

  at hospital discharge

Study Arms (3)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital Amstetten: lead

Study Sites (1)

General Hospital Amstetten

Amstetten, 3300, Austria

Location

Limitations and Caveats

The study is retrospective and all patients during the timeframe (who signed the patient informed consent) have been included into the study.

Results Point of Contact

• Title: Wolfgang Senker, MD
• Organization: General Hospital Amstetten

wolfgang.senker@aon.at

+43 7472 6040

Study Officials

• Wolfgang Senker, MD

  General Hospital Amstetten

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 6, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: April 3, 2015
• Results First Posted: September 21, 2011

Record last verified: 2015-03

Locations

AU (1)