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

Degenerative Lumbar Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195584
• Other study ID #: 1-Senker
• Status: Completed
• Phase: N/A
• First received: September 3, 2010
• Last updated: March 16, 2015
• Start date: May 2010
• Est. completion date: July 2010

Study information

• Verified date: March 2015
• Source: General Hospital Amstetten
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Degenerative Lumbar Disease

Locations

Country	Name	City	State
Austria	General Hospital Amstetten	Amstetten

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital Amstetten

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Operation Duration	Duration of the operation in minutes.	after surgery	No
Secondary	Blood Loss	Loss of blood during surgical procedure in milliliters.	after surgery	No
Secondary	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	No
Secondary	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	No
Secondary	Days of Hospitalization	Total time of hospitalization.	at hospital discharge	No